Identifiers
- 510(k) Number
- K983393 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
- ST FDA 510(k)
The LifePak 500 Biphasic is an Automated External Defibrillator (Non-Wearable), designed to deliver biphasic waveform shocks for the resuscitation of patients experiencing sudden cardiac arrest. It provides automated analysis of heart rhythms and delivers appropriate defibrillation therapy when indicated, with voice prompts to guide rescuers through the resuscitation process.
Supplied as a reusable device, the LifePak 500 Biphasic is intended for use in pre-hospital and in-hospital settings, including emergency medical services, hospitals, and public access defibrillation programs. It is classified as a Class III medical device under FDA regulations (870.5310) and holds a 510(k) clearance with tracking requirements. The device is not MRI-safe and requires proper storage and maintenance as specified by the manufacturer.
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 | K983393 | Class III | Active |
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Manufacturer
- Manufacturer
- Physio-Control Corp.
Sources (1)
- FDA 510(k) K983393 24 fields · synced Sep 18, 2026