510(k) K851194 ยท BYE Attachment, Breathing, Positive End Expiratory Pressure
AMBU CPAP SYSTEM
| Applicant | Ambu, Inc., Danbury CT, US |
| Decision | Substantially Equivalent, Apr 15, 1985 |
| Received | Mar 26, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K851194
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.