510(k) K981668 ยท CBK Ventilator, Continuous, Facility Use
SMARTVENT 201 PORTABLE VENTILATOR
| Applicant | Versamed , Ltd., Ra'Ananna 43373, IL |
| Decision | Substantially Equivalent, Apr 7, 1999 |
| Received | May 11, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981668
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.