510(k) K162832 ยท CBK Ventilator, Continuous, Facility Use
731 Series Ventilators
| Applicant | ZOLL Medical Corporation, Chelsmford MA, US |
| Decision | Substantially Equivalent, Aug 2, 2017 |
| Received | Oct 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162832
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.