510(k) K051262 ยท CBK Ventilator, Continuous, Facility Use
ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000
| Applicant | Respironics California, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jul 8, 2005 |
| Received | May 16, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051262
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2009 | Respironics California Inc Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; Product Number: 1001456. Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.