510(k) K103318 ยท CBK Ventilator, Continuous, Facility Use
UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR
| Applicant | Impact Instrumentation, Inc., West Caldwell NJ, US |
| Decision | Substantially Equivalent, Apr 7, 2011 |
| Received | Nov 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103318
| 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 |
| Aug 7, 2012 | Impact Instrumentation, Inc. Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.