510(k) K822319 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
RE1000 HEART RATE MONITOR
| Applicant | Electronic Monitors, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Sep 14, 1982 |
| Received | Aug 3, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K822319
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.