510(k) K211289 ยท DRM Compressor, Cardiac, External
RMU-2000 Automated Chest Compression System
| Applicant | Defibtech, LLC, Guilford CT, US |
| Decision | Substantially Equivalent, Nov 9, 2021 |
| Received | Apr 28, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211289
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2024 | Defibtech, LLC RMU-2000 Automated Chest Compression Device Open, Classified |
DRM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.