Identifiers
- 510(k) Number
- K832876 FDA 510(k)
- FDA Product Code
- DRO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5550 FDA 510(k)
- Regulation Number
- 870.5550 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Lifepak 7p is an External Transcutaneous Pacemaker, Cardiac, Non-Invasive device. It is a basic monitor defibrillator with a built-in recorder and can be powered by battery or AC power. The device meets current ACLS standards and is used in cardiovascular applications.
The Lifepak 7p is supplied by Physio-Control Corp. and has been cleared by the FDA with a Traditional 510(k) clearance. The device has a product code of DRO and is regulated under regulation number 870.5550. It is intended for use in a clinical or EMS environment and is designed to provide cardiac monitoring and defibrillation capabilities.
Frequently asked questions
What is the Lifepak 7p used for?
The Lifepak 7p is used for cardiac monitoring and defibrillation in clinical or EMS environments, providing basic monitoring and defibrillation capabilities.
Is the Lifepak 7p cleared by the FDA?
Yes, the Lifepak 7p has been cleared by the FDA with a Traditional 510(k) clearance, indicating it is substantially equivalent to a predicate device.
What power options are available for the Lifepak 7p?
The Lifepak 7p can be powered by either battery or AC power, providing flexibility in different use environments.
What type of device is the Lifepak 7p?
The Lifepak 7p is an External Transcutaneous Pacemaker, Cardiac, Non-Invasive device, classified under product code DRO and regulated under regulation number 870.5550.
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: LIFEPAK 7P (K832876) — FDA 510(k) | Innolitics, Physio-Control LIFEPAK Defibrillators - AEDSuperstore, Physio-Control Corp. — 80 FDA 510 (k)s · DeviceClearance, Physio-Control - LifePak 7 Community, Manuals and Specifications ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K832876 | Class II | Active |
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Manufacturer
- Manufacturer
- Physio-Control Corp.
Sources (1)
- FDA 510(k) K832876 24 fields · synced Sep 24, 2026