510(k) K091238 ยท CBK Ventilator, Continuous, Facility Use
UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+
| Applicant | Impact Instrumentation, Inc., West Caldwell NJ, US |
| Decision | Substantially Equivalent, Aug 13, 2009 |
| Received | Apr 27, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091238
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2017 | ZOLL Medical Corporation 731 Series Ventilators running software version 05.20.00
The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or c Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.