510(k) K970158 ยท CBK Ventilator, Continuous, Facility Use
BABYPAC
| Applicant | Pneupac, Inc., Wake Forest NC, US |
| Decision | Substantially Equivalent, Apr 28, 1998 |
| Received | Jan 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970158
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.