510(k) K960861 ยท CBK Ventilator, Continuous, Facility Use
OMICRON MONITOR, DELTA MONITOR
| Applicant | Core-M, Inc., Allston MA, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Aug 19, 1996 |
| Received | Mar 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960861
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.