510(k) K860077 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
SG-066 OXYGEN ENRICHMENT KIT
| Applicant | Instrumentation Industries, Inc., Bethel Park PA, US |
| Decision | Substantially Equivalent, Feb 18, 1986 |
| Received | Jan 8, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860077
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.