510(k) K191955 ยท DRN Device, Counter-Pulsating, External
Enhanced External Counter Pulsation Device Plus Omay-A
| Applicant | Omay(Guangzhou)Med Technologies Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Aug 5, 2020 |
| Received | Jul 22, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191955
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.