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 |