510(k) K820943 ยท FLS Monitor, Apnea, Facility Use
SYSTEM I INFANT MONITORING SYS
| Applicant | Burr Engineering & Development Co., Mchenry IL, US |
| Decision | Substantially Equivalent, May 3, 1982 |
| Received | Apr 6, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820943
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.