K211289 is an FDA 510(k) clearance for the RMU-2000 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 November 9, 2021, 195 days after receiving the submission on April 28, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5200.
| 510(k) Number | K211289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 2021 |
| Decision Date | November 09, 2021 |
| Days to Decision | 195 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 |