510(k) K970959 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)
| Applicant | Instrumentation Industries, Inc., Bethel Park PA, US |
| Decision | Substantially Equivalent, Jun 13, 1997 |
| Received | Mar 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970959
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.