510(k) K111473 ยท CBK Ventilator, Continuous, Facility Use
UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR
| Applicant | Impact Instrumentation, Inc., West Caldwell NJ, US |
| Decision | Substantially Equivalent, Feb 16, 2012 |
| Received | May 27, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111473
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 20, 2024 | ZOLL Medical Corporation ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRGs) as follows:
Part Numbers:
1. 799-EGL2-02
2. 799-EGL2-02-01
3. 799-EGL2-02- Open, Classified |
CBK | None listed |
| 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.