510(k) K202108 ยท DRN Device, Counter-Pulsating, External
External Counterpulsation System, Soulaire
| Applicant | Vamed Medical Instrument Co., Ltd., Foshan, CN |
| Decision | Substantially Equivalent, Aug 28, 2020 |
| Received | Jul 30, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K202108
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.