Identifiers
- 510(k) Number
- K833879 FDA 510(k)
- FDA Product Code
- DRM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5200 FDA 510(k)
- Regulation Number
- 870.5200 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Cardiac, External Compressor, classified under FDA Product Code DRM, designed to provide mechanical chest compressions during cardiopulmonary resuscitation (CPR). It is intended to assist in maintaining circulation and oxygenation when manual CPR is impractical or insufficient, particularly in training, testing, or emergency scenarios.
The Cardiopulmonary Resuscitator is supplied as a reusable mechanical device, regulated under FDA 510(k) clearance (K833879) and classified as a Class II medical device. It is intended for use in medical and educational settings, adhering to Cardiovascular Device Facts standards. No specific sterility or MRI safety information is provided in the data, and its operational parameters are governed by the DRM product classification.
Frequently asked questions
What is the purpose of the Cardiopulmonary Resuscitator?
This device provides mechanical chest compressions during CPR to maintain circulation and oxygenation when manual CPR is impractical or insufficient, particularly in training, testing, or emergency scenarios.
Is the Cardiopulmonary Resuscutator a single-use device?
No, this device is supplied as a reusable mechanical device designed for multiple uses in medical and educational settings.
What regulatory classification applies to this device?
The Cardiopulmonary Resuscitator is classified under FDA Product Code DRM as a Class II medical device with FDA 510(k) clearance K833879.
In what settings is this device intended to be used?
It is intended for use in medical and educational settings where mechanical chest compressions are needed during cardiopulmonary resuscitation.
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: Test Lung Simulation & Automated CPR Devices - Michigan Instruments, THUMPER CARDIOPULMONARY RESUSCITATOR 1005 (K851139) — FDA 510(k ..., CARDIOPULMONARY RESUSCITATOR (K833879) — FDA 510(k) | Innolitics, Class 3 Device Recall Thumper mechanical cardiopulmonary resuscitator
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K833879 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Michigan Instruments, Inc.
Sources (1)
- FDA 510(k) K833879 24 fields · synced Sep 19, 2026