Heartstart Mrx, Model M3535a
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K031187 FDA 510(k)
- FDA Product Code
- MKJ FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5310 FDA 510(k)
- Regulation Number
- 870.5310 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HeartStart MRX Monitor/Defibrillator, Model M3535A, is an automated external defibrillator designed for emergency cardiac resuscitation. It delivers synchronized cardioversion and defibrillation therapies while providing real-time ECG monitoring, including 12-lead ECG capabilities via the DXL algorithm, to assess cardiac rhythms and guide resuscitation efforts.
This device is intended for use in pre-hospital and emergency care settings, offering both single-use and reusable configurations depending on the application. Supplied as a Class III medical device under FDA 510(k) clearance (K031187), it is regulated under 21 CFR 870.5310 and requires proper training for operation. The device is not MRI-safe and must be stored in accordance with manufacturer guidelines to maintain functionality and sterility.
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: Philips - HeartStart MRx Monitor/Defibrillator for emergency care, Philips M3535A, M3536A User manual - ManualMachine.com, Philips M3535A HeartStart MRx User manual, Philips HeartStart MRx M3535A/M3536A Service Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K031187 | Class III | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems
Sources (1)
- FDA 510(k) K031187 24 fields · synced Sep 18, 2026