Zeto ONE REF Cable Extension

GUDID B675ONEREF1

The Zeto ONE REF Cable Extension is an accessory 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 REF Cable Extension is a lead wire with 2.5 mm jack connector at one end, and a snap-on connector for commonly available adhesive electrodes at the other end. The lead wire is used as a reference cable during EEG recording sessions.

ZETO INC

Electroencephalograph

• Primary Device ID: B675ONEREF1
• NIH Device Record Key: 4b659c73-0f14-4cff-a7c5-94961e399821
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zeto ONE REF Cable Extension
• Version Model Number: ZP-230-30061
• Company DUNS: 079582566
• Company Name: ZETO INC
• Device Count: 1
• DM Exempt: false
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B675ONEREF1 [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

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