| Primary Device ID | B675ONEECG1 |
| NIH Device Record Key | b68241a7-ccc2-4a0f-8168-aa1b1747dd9b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zeto ONE ECG Cable Extension Set |
| Version Model Number | ZP-230-30011 |
| 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 |
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| B675ONEECG1 - Zeto ONE ECG Cable Extension Set | 2024-06-19The Zeto ONE ECG 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 ECG 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 electrocardiogram signals. |
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