510(k) K051322 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS
| Applicant | Smiths Medical International , Ltd., Waukesha WI, US |
| Decision | Substantially Equivalent, Aug 5, 2005 |
| Received | May 20, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051322
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 4, 2007 | Smiths Medical PM, Inc. Pneupac VR1 Standard and VR1 Responder is a hand held portable, time cycled, gas powered, flow generator ventilatory resuscitators that are intended for emergency resuscitation by medical personnel, p Terminated |
BTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.