Identifiers
- 510(k) Number
- K832833 FDA 510(k)
- FDA Product Code
- LDD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5300 FDA 510(k)
- Regulation Number
- 870.5300 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Personal Defibrillator is a low-energy defibrillator, including paddles, used in cardiovascular applications. It is a type of dc-defibrillator. The device is used to apply an electrical shock to the heart.
The Personal Defibrillator is supplied with FDA 510K authorizations. It is classified as a class 2 device with the regulation number 870.5300. The device has a product code of LDD and is registered with the registration number 1930027, among others.
Frequently asked questions
What is the Personal Defibrillator used for?
The Personal Defibrillator is used to apply an electrical shock to the heart in cardiovascular applications.
Is the Personal Defibrillator supplied with any authorizations?
Yes, the Personal Defibrillator is supplied with FDA 510K authorizations.
What type of device is the Personal Defibrillator classified as?
The Personal Defibrillator is classified as a class 2 device with the regulation number 870.5300.
What is the product code of the Personal Defibrillator?
The product code of the Personal Defibrillator is LDD.
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 AEDs | LIFEPAK CR2 & 1000 Defibrillators, Physio-Control AEDs and Defibrillators - CardiacDirect, Physio-Control (Stryker) LifePak | The AED Depot, Physio-Control AEDs | Total AEDs, Physio-Control International Corp. — Company History
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K832833 | Class II | Active |
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Manufacturer
- Manufacturer
- PHYSIO-CONTROL, Inc.
Sources (1)
- FDA 510(k) K832833 24 fields · synced Sep 27, 2026