510(k) K011957 ยท CBK Ventilator, Continuous, Facility Use
IVENT 201 PORTABLE VENTILATOR
| Applicant | Versamed , Ltd., Tel-Aviv, IL |
| Decision | Substantially Equivalent, Jul 18, 2001 |
| Received | Jun 22, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K011957
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.