510(k) K991785 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR
| Applicant | Instrumentation Industries, Inc., Bethel Park PA, US |
| Decision | Substantially Equivalent, Aug 17, 1999 |
| Received | May 25, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991785
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 16, 2013 | Instrumentation Industries Inc Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/I Terminated |
BTL | None listed |
| Feb 27, 2004 | Instrumentation Industries Inc BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator Terminated |
BTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.