Identifiers
- 510(k) Number
- K973486 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 LifePak 12 is an Automated External Defibrillator (Non-Wearable), designed to deliver defibrillation therapy, synchronized cardioversion, and noninvasive pacing for patients experiencing life-threatening cardiac arrhythmias. It provides automated rhythm analysis and shock advisory guidance, alongside manual override capabilities for clinical flexibility.
Supplied as a reusable device, the LifePak 12 is intended for use in prehospital, emergency department, and clinical settings. It operates in both automated and manual modes, with no specified MRI safety classification. Authorized under FDA 510(k) clearance (K973486), it adheres to regulatory standards for cardiovascular emergency response devices, including compliance with 21 CFR 870.5310.
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: Physio Control Lifepak 12 Defibrillator - Global Medical Devices, Physio-control LIFEPAK 12 Manuals | ManualsLib, Physio Lifepak 12 Defibrillator/Monitor
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K973486 | Class III | Active |
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Manufacturer
- Manufacturer
- Physio-Control Corp.
Sources (1)
- FDA 510(k) K973486 24 fields · synced Sep 18, 2026