510(k) K964719 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR
| Applicant | Hudson Respiratory Care, Inc., Temecula CA, US |
| Decision | Substantially Equivalent, Feb 21, 1997 |
| Received | Nov 25, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964719
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2015 | Teleflex Medical Lifesaver Single Patient Use Manual Resuscitator
Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended Terminated |
BTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.