K141809 is an FDA 510(k) clearance for the RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM. This device is classified as a Compressor, Cardiac, External (Class II - Special Controls, product code DRM).
Submitted by Defibtech, LLC (Guilford, US). The FDA issued a Cleared decision on October 27, 2014, 112 days after receiving the submission on July 7, 2014.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5200.
| 510(k) Number | K141809 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2014 |
| Decision Date | October 27, 2014 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRM — Compressor, Cardiac, External |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5200 |