Airstrip Remote Patient Monitoring
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K133450 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)
Airstrip Remote Patient Monitoring is a mobile-enabled application designed to provide near real-time and historical clinical data for patient surveillance. The system integrates patient waveforms and clinical insights to support alarm management and predictive analytics for the clinical team.
This software is accessed via mobile devices and the web to facilitate the review of patient data and communication among clinicians. It is authorized under FDA 510K clearance and is designed to integrate with various cardiac and patient monitoring systems.
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 Patient Monitoring | Near Real-Time Mobile & Web Monitoring, AirStrip® | Clinical Surveillance, Alarms, and Predictive Analytics, AirStrip | GE HealthCare (United States)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133450 | Class II | Active |
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Manufacturer
- Manufacturer
- Airstrip Technologies, LP
Sources (1)
- FDA 510(k) K133450 24 fields · synced Oct 6, 2026