Zeto ONE Head Unit

GUDID B675ONEHU1

The Zeto ONE Head Unit is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The Head Unit component of the Zeto ONE is intended to hold electrodes on the subject's scalp and aquire electric signals produced by human brain activity.

ZETO INC

Electroencephalograph

• Primary Device ID: B675ONEHU1
• NIH Device Record Key: 94734fdc-2b8b-4df8-963e-4abc110b9332
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zeto ONE Head Unit
• Version Model Number: ZP-120-11011
• Company DUNS: 079582566
• Company Name: ZETO INC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8339386334
• Email: support@zetoinc.com
• Phone: 8339386334
• Email: support@zetoinc.com
• Phone: 8339386334
• Email: support@zetoinc.com
• Phone: 8339386334
• Email: support@zetoinc.com
• Phone: 8339386334
• Email: support@zetoinc.com
• Phone: 8339386334
• Email: support@zetoinc.com
• Phone: 8339386334
• Email: support@zetoinc.com
• Phone: 8339386334
• Email: support@zetoinc.com
• Phone: 8339386334
• Email: support@zetoinc.com
• Phone: 8339386334
• Email: support@zetoinc.com
• Phone: 8339386334
• Email: support@zetoinc.com
• Phone: 8339386334
• Email: support@zetoinc.com
• Phone: 8339386334
• Email: support@zetoinc.com
• Phone: 8339386334
• Email: support@zetoinc.com
• Phone: 8339386334
• Email: support@zetoinc.com
• Phone: 8339386334
• Email: support@zetoinc.com

Device Dimensions

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Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -20 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 12 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 45 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between -20 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B675ONEHU1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233403

FDA Product Code

• GWQ: Full-Montage Standard Electroencephalograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-19
• Device Publish Date: 2024-06-11

Devices Manufactured by ZETO INC

• B675ONEHUL1 - Zeto ONE Head Unit - Regular: 2025-07-17 The Zeto ONE Head Unit - Regular is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in h
• B675ONEHUS1 - Zeto ONE Head Unit - Small: 2025-07-17 The Zeto ONE Head Unit - Small is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in hea
• B675ONELTES1 - Zeto ONE Long-Term Electrode Set: 2025-07-17 The Zeto ONE Long-Term Electrode Set is a part of the Zeto ONE, which is an EEG system intended for prescription use in a health
• B675ONESTES1 - Zeto ONE Short-Term Electrode Set: 2025-07-17 The Zeto ONE Short-Term Electrode Set is a part of the Zeto ONE, which is an EEG system intended for prescription use in a healt
• B675DC0 - Zeto ONE Disinfection Container with Lid: 2024-11-28 The Zeto ONE Disinfection Container with Lid is an accessory of the Zeto ONE, which is an EEG system intended for prescription u
• B675MM0 - Zeto All-in-One Medical Grade PC: 2024-11-28 The "Zeto All-in-One Medical Grade PC" is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in
• B675ONEAUX1 - Zeto ONE AUX Cable Extension Set: 2024-06-19 The Zeto ONE AUX Cable Extension Set is an accessory of the Zeto ONE, which is an EEG system intended for prescription use in he
• B675ONEDU0 - Zeto ONE Display Unit: 2024-06-19 The Zeto ONE Display Unit (DU) is a part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare fac