Zeto ONE AUX Cable Extension Set

GUDID B675ONEAUX1

The Zeto ONE AUX Cable Extension Set 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 AUX Cable Extension Set is a pair of lead wires with 2.5 mm jack connectors at one end, and snap-on connectors for commonly available adhesive electrodes at the other end. The lead wires are used to record auxiliary signals.

ZETO INC

Electroencephalograph

• Primary Device ID: B675ONEAUX1
• NIH Device Record Key: 41712a02-43e5-4803-ab74-17bff4ee09f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zeto ONE AUX Cable Extension Set
• Version Model Number: ZP-230-30021
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B675ONEAUX1 [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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