510(k) K162793 ยท DQK Computer, Diagnostic, Programmable
RHYTHMIA HDx Mapping System
| Applicant | Boston Scientific Corporation, Cambridge MA, US |
| Decision | Substantially Equivalent, Mar 10, 2017 |
| Received | Oct 4, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162793
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.