HeartStream XL Defibrillator/Monitor, Model M4735A
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K001725 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 HeartStream XL Defibrillator/Monitor, Model M4735A, is an Automated External Defibrillator (Non-Wearable) designed to deliver synchronized cardioversion and defibrillation while continuously monitoring cardiac rhythms. It provides real-time ECG analysis, shock delivery, and pacing capabilities to support emergency cardiac interventions in both pre-hospital and clinical settings.
This device is intended for single-use applications and is supplied as a reusable medical device with appropriate sterilization procedures. It is classified as a Class III medical device under FDA regulations (870.5310) and has received FDA 510K clearance through a traditional review process. The device is intended for use in environments requiring reliable cardiac monitoring and defibrillation, including emergency rooms, ambulances, and cardiac care units.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K001725 | Class III | Active |
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Manufacturer
- Manufacturer
- Agilent Technologies, Inc.
Sources (1)
- FDA 510(k) K001725 24 fields · synced Sep 18, 2026