Airstrip Remote Patient Monitoring Philips Adapter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K131786 FDA 510(k)
- FDA Product Code
- MWI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2300 FDA 510(k)
- Regulation Number
- 870.2300 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Airstrip Remote Patient Monitoring Philips Adapter is a software application designed for mobile devices, including cellular phones and wireless devices. It functions as a secondary display system that enables the remote viewing of physiologic data and waveforms captured from hospital-based patient monitoring and information systems.
This device is classified as a Class II physiological patient monitor without arrhythmia detection or alarms. It received FDA 510(k) clearance on July 3, 2013, under the product code MWI. The system is intended for clinical use as a secondary monitoring interface.
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: Airstrip Remote Patient Monitoring Philips Adapter, K131786 FDA 510(k) - AIRSTRIP REMOTE PATIENT MONITORING PHIL..., airstrip remote patient monitoring philips adapter, AirStrip® | Clinical Surveillance, Alarms, and Predictive Analytics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131786 | Class II | Active |
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Manufacturer
- Manufacturer
- Airstrip Technologies, LP
Sources (1)
- FDA 510(k) K131786 24 fields · synced Oct 6, 2026