510(k) K910194 ยท BZD Ventilator, Non-Continuous (Respirator)
COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM
| Applicant | Puritan Bennett Corp., Overland Park KS, US |
| Decision | Substantially Equivalent, May 13, 1991 |
| Received | Jan 16, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910194
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.