510(k) K864261 ยท BZQ Monitor, Breathing Frequency
MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR
| Applicant | Bio-Dyne, Inc., Milford CT, US |
| Decision | Substantially Equivalent, Mar 27, 1987 |
| Received | Oct 29, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864261
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.