The following data is part of a premarket notification filed by Resuscitation International, Llc with the FDA for Rosc-u Mini Chest Compressor (rmcc).
| Device ID | K153628 |
| 510k Number | K153628 |
| Device Name: | ROSC-U Mini Chest Compressor (RMCC) |
| Classification | Compressor, Cardiac, External |
| Applicant | Resuscitation International, LLC 17797 N. PERIMETER DR., STE D-105 Scottsdale, AZ 85255 |
| Contact | Hayden Fleming |
| Correspondent | Hayden Fleming Resuscitation International, LLC 17797 N. PERIMETER DR., STE D-105 Scottsdale, AZ 85255 |
| Product Code | DRM |
| CFR Regulation Number | 870.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-18 |
| Decision Date | 2016-01-30 |