Zeto ONE Head Unit - Regular

GUDID B675ONEHUL1

The Zeto ONE Head Unit - Regular 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 with head circumference of approximately 50-65 cm, not including newborns. The Head Unit - Regular 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: B675ONEHUL1
• NIH Device Record Key: a4169b82-3ea7-43aa-8062-11e1948e93f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zeto ONE Head Unit - Regular
• Version Model Number: ZP-120-11031
• Company DUNS: 079582566
• Company Name: ZETO INC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B675ONEHUL1 [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: 2025-07-17
• Device Publish Date: 2025-07-09

On-Brand Devices [Zeto ONE Head Unit - Regular]

• B675ONEHUL1: The Zeto ONE Head Unit - Regular is a detachable part of the Zeto ONE, which is an EEG system in
• B675ONEHUL0: The Zeto ONE Head Unit - Regular is a detachable part of the Zeto ONE, which is an EEG system in