LifePak 20 Defibrillator/Monitor, LifePak 20E Defibrillator/Monitor
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K130454 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 20 and LifePak 20E are automated external defibrillators (non-wearable) designed to deliver synchronized and unsynchronized electrical shocks for cardiac resuscitation. They continuously monitor heart rhythms, provide real-time ECG waveforms, and offer both manual and automated defibrillation capabilities for emergency cardiac care.
These devices are intended for single-use or reusable applications in pre-hospital, hospital, and clinical settings, depending on the model variant. Supplied sterile or non-sterile as specified, they comply with FDA 510(k) clearance under the classification of Class III medical devices. The LifePak 20E variant includes advanced features such as wireless data transmission for integration into resuscitation management systems, while both models adhere to MRI safety standards for non-ferromagnetic components.
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: PDF LIFEPAK 20e monitor/defibrillator brochure - Stryker, Lifepak 20e Monitor/Defibrillator, PDF LIFEPAK 20e DEFIBRILLATOR/MONITOR - avobus.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130454 | Class III | Active |
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Manufacturer
- Manufacturer
- PHYSIO-CONTROL, Inc.
Sources (1)
- FDA 510(k) K130454 24 fields · synced Oct 6, 2026