510(k) K061627 ยท CBK Ventilator, Continuous, Facility Use
MODIFICATION TO I VENT 201
| Applicant | Versamed Medical Systems, Inc., Pearl River NY, US |
| Decision | Substantially Equivalent, Jun 29, 2006 |
| Received | Jun 12, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061627
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.