Nellcor Pulse Oximetry Monitor Interface Cable
FDA 510(k)Class II (US FDA 510(k))
by Covidien
Identifiers
- 510(k) Number
- K172482 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nellcor Pulse Oximetry Monitor Interface Cable is a cable designed to facilitate communication between a pulse oximetry monitor and its sensors. It enables the transmission of oxygen saturation (SpO₂) and pulse rate data from the sensor to the monitoring device, ensuring accurate patient monitoring in clinical settings.
This cable is supplied as a reusable accessory for use with Nellcor pulse oximetry systems. It is intended for integration with compatible monitoring platforms and is not subject to sterility requirements. The device is regulated under FDA 510(k) clearance (K172482) and falls under the product code DQA, with no specific MRI safety restrictions stated. Storage should follow manufacturer guidelines for electronic medical devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Covidien > Nellcor Compatible SpO2 Adapter Cable - DOC-4, Nellcor™ OxiCable - Medtronic, Nellcor Pulse Oximeter | Cables and Sensors
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172482 | Class II | Active |
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Manufacturer
- Manufacturer
- Covidien
Sources (1)
- FDA 510(k) K172482 24 fields · synced Sep 19, 2026