510(k) K962865 ยท FLS Monitor, Apnea, Facility Use
REMBRANDT SYSTEM
| Applicant | Airsep Corp., Buffalo NY, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Oct 25, 1996 |
| Received | Jul 23, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962865
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.