Miniaturize Chest Compressor (MCC)
FDA 510(k) K102068 · Resuscitation International
510(k) numberK102068
Submission
- Device name
- Miniaturize Chest Compressor (MCC)
- Applicant
- Resuscitation International
Irvine, CA, US - Received
- July 23, 2010
- Decision date
- November 16, 2010
- 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 |
| K211289 | RMU-2000 Automated Chest Compression SystemDRM · Traditional | Defibtech, LLC | 11/09/2021SE |
| 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 |
| 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 |
|---|---|---|
| K153628 | ROSC-U Mini Chest Compressor (RMCC)DRM · Traditional | 01/30/2016SE |
Questions and answers
When was Miniaturize Chest Compressor (MCC) cleared by the FDA?
Miniaturize Chest Compressor (MCC) (K102068) received a 510(k) decision of Substantially Equivalent on November 16, 2010, 116 days after the submission was received.
What is the product code of K102068?
The FDA product code is DRM – Compressor, Cardiac, External, a Class II (moderate risk) device regulated under 21 CFR 870.5200.