510(k) K973975 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
RESPIRTECHPRO
| Applicant | Vortran Medical Technology 1, Inc., Sacramento CA, US |
| Decision | Substantially Equivalent, Jun 12, 1998 |
| Received | Oct 20, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973975
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2017 | Vortran Medical Technology 1, Inc VORTRAN Automatic Resuscitator, VARPlus;
Model PTE-5002; Qty: 10 each
Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure Terminated |
BTL | None listed |
| Apr 25, 2017 | Vortran Medical Technology 1, Inc VORTRAN Automatic Resuscitator, VARPlus with Extension Kit;
Model PCE-5012; Qty: 10 each.
Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, con Terminated |
BTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.