DRM — Compressor, Cardiac, External Class II
FDA product code DRM covers "Compressor, Cardiac, External", a Class II medical device regulated under 21 CFR 870.5200. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DRM
- Device Class
- Class II
- Regulation Number
- 870.5200
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K221700 | zoll circulation | AutoPulse NXT Resuscitation System | March 9, 2023 |
| K211289 | defibtech | RMU-2000 Automated Chest Compression System | November 9, 2021 |
| K173553 | jolife | LUCAS 3 Chest Compression System | February 8, 2018 |
| K161768 | jolife | LUCAS 3 Chest Compression System | November 9, 2016 |
| K153628 | resuscitation international | ROSC-U Mini Chest Compressor (RMCC) | January 30, 2016 |
| K141809 | defibtech | RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM | October 27, 2014 |
| K112998 | zoll circulation | AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 | March 15, 2012 |
| K102068 | resuscitation international | MINIATURIZE CHEST COMPRESSOR (MCC) | November 16, 2010 |
| K090422 | jolife | LUCAS 2 | June 17, 2009 |
| K072527 | zoll circulation | AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 | March 19, 2008 |
| K073079 | michigan instruments | THUMPER, MODEL: 1008 | February 14, 2008 |
| K063602 | zoll circulation | AUTOPULSE RESUSCITATION SYSTEM MODEL100 | December 21, 2006 |
| K062401 | jolife | MODIFICATION TO LUCAS | September 28, 2006 |
| K062119 | medical products mfg | HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100 | September 22, 2006 |
| K053403 | jolife | LUCAS | February 1, 2006 |
| K024215 | enertron engineering | ENERTRON CPR JACK | May 14, 2004 |
| K040453 | revivant | AUTOPULSE RESUSCITATION SYSTEM, MODEL 100 | March 11, 2004 |
| K032852 | revivant | MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100 | November 12, 2003 |
| K022345 | revivant | AUTOPULSE RESUSCITATION SYSTEM | August 15, 2002 |
| K011046 | revivant | AUTOPULSE, MODEL 100 | October 25, 2001 |