510(k) K121722 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
ESA620 ELECTRICAL SAFETY ANALYZER
| Applicant | Fluke Biomedical, Cleveland OH, US |
| Decision | Substantially Equivalent, Oct 11, 2012 |
| Received | Jun 12, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121722
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.