510(k) K922178 ยท BYE Attachment, Breathing, Positive End Expiratory Pressure
COMPANION 318 NASAL CPAP SYSTEM -- MODIFICATION
| Applicant | Puritan Bennett Corp., Lenexa KS, US |
| Decision | Substantially Equivalent, May 29, 1992 |
| Received | May 8, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922178
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.