510(k) K192438 ยท DQK Computer, Diagnostic, Programmable
Rhythmia HDxTM Mapping System
| Applicant | Boston Scientific Corporation, Cambridge MA, US |
| Decision | Substantially Equivalent, Nov 27, 2019 |
| Received | Sep 6, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192438
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.