510(k) K052554 ยท CBK Ventilator, Continuous, Facility Use
MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR
| Applicant | Versamed Medical Systems, Inc., Pearl River NY, US |
| Decision | Substantially Equivalent, Sep 23, 2005 |
| Received | Sep 16, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052554
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.