510(k) K830778 ยท FLS Monitor, Apnea, Facility Use
MONITORING KIT AMK-1
| Applicant | Alternative Design Systems, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 14, 1983 |
| Received | Mar 11, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830778
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.