RMU-2000 Automated Chest Compression System
FDA 510(k) K211289 · Defibtech, LLC
510(k) numberK211289
Submission
- Device name
- RMU-2000 Automated Chest Compression System
- Applicant
- Defibtech, LLC
Guilford, CT, US - Received
- April 28, 2021
- Decision date
- November 9, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRM – Compressor, Cardiac, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5200
- Specialty
- Cardiovascular
Other 510(k)s with product code DRM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221700 | AutoPulse NXT Resuscitation SystemDRM · Traditional | Zoll Circulation, Inc. | 03/09/2023SE |
| K173553 | LUCAS 3 Chest Compression SystemDRM · Traditional | Jolife AB | 02/08/2018SE |
| K161768 | LUCAS 3 Chest Compression SystemDRM · Traditional | Jolife AB | 11/09/2016SE |
| K153628 | ROSC-U Mini Chest Compressor (RMCC)DRM · Traditional | Resuscitation International, LLC | 01/30/2016SE |
| K141809 | RMU-1000 Automated Chest Compression SystemDRM · Traditional | Defibtech, LLC | 10/27/2014SE |
| K112998 | Autopulse Resuscitation System Model 1000DRM · Traditional | Zoll Circulation | 03/15/2012SE |
| K102068 | Miniaturize Chest Compressor (MCC)DRM · Traditional | Resuscitation International | 11/16/2010SE |
| K090422 | Lucas 2DRM · Traditional | Jolife AB | 06/17/2009SE |
| K072527 | Autopulse Resuscitation System, Model 100DRM · Traditional | Zoll Circulation | 03/19/2008SE |
| K073079 | Thumper, Model: 1008DRM · Traditional | Michigan Instruments, Inc. | 02/14/2008SE |
More from Michigan Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K141809 | RMU-1000 Automated Chest Compression SystemDRM · Traditional | 10/27/2014SE |
| K131525 | Semiautomatic External Defibrillator and AccessoriesMKJ · Traditional | 04/24/2014SE |
| K113787 | DDU-120 Fully Automatic External Defibrillator and AccessoriesMKJ · Traditional | 01/04/2013SE |
| K121853 | DDU-2400/2450 Semiautomatic External Defibrillator and AccessoriesMKJ · Traditional | 12/13/2012SE |
| K081259 | DDU-2300 Semiautomatic External Defibrillator and AccessoriesMKJ · Traditional | 06/15/2009SE |
| K033896 | Defibtech AED with Attenuated Defibrillation/Monitoring Pads, Models DDU-100 with DDP-200PMKJ · Traditional | 06/16/2004SE |
| K033144 | Defibtech Electrode Adapter, Model DAC-300 SeriesMKJ · Traditional | 11/13/2003SE |
| K013896 | Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes)…MKJ · Traditional | 06/19/2002ST |
Questions and answers
When was RMU-2000 Automated Chest Compression System cleared by the FDA?
RMU-2000 Automated Chest Compression System (K211289) received a 510(k) decision of Substantially Equivalent on November 9, 2021, 195 days after the submission was received.
What is the product code of K211289?
The FDA product code is DRM – Compressor, Cardiac, External, a Class II (moderate risk) device regulated under 21 CFR 870.5200.