510(k) K943243 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
PULSE HEART RATE MONITOR
| Applicant | Sensor Dynamics, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Mar 10, 1995 |
| Received | Jul 6, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943243
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.