510(k) K182344 ยท DQK Computer, Diagnostic, Programmable
RhythmAnalytics
| Applicant | Biofourmis Singapore Pte., Ltd., Singapore, SG |
| Decision | Substantially Equivalent, Mar 7, 2019 |
| Received | Aug 28, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182344
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.