HeartStart MRX (Models M3535A or M3536A)
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K063375 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 (Models M3535A or M3536A) is an Automated External Defibrillator (Non-Wearable), designed to deliver defibrillation therapies and continuous cardiac monitoring. It provides real-time ECG analysis, automated shock advisory, and 12-lead ECG reporting for rapid assessment of cardiac events.
This device is intended for use in pre-hospital, emergency, and clinical settings by trained personnel. Supplied as a reusable medical device, it requires proper maintenance, calibration, and adherence to manufacturer guidelines for safe operation. The HeartStart MRX is classified as a Class III device under FDA regulations and holds a Special 510(k) clearance for cardiovascular applications.
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 M3535A/M3536A Service Manual, Philips M3535A, M3536A User Manual, Philips M3535A, M3536A User manual - ManualMachine.com, HeartStart MRx monitor/defibrillator M3535A, M3536A ... - manualzz
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K063375 | Class III | Active |
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Manufacturer
- Manufacturer
- Philips Medical Systems
Sources (1)
- FDA 510(k) K063375 24 fields · synced Sep 18, 2026