510(k) K980365 ยท BZD Ventilator, Non-Continuous (Respirator)
GOODKNIGHT 418 CPAP SYSTEM
| Applicant | Nellcor Puritan Bennett, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jul 22, 1998 |
| Received | Jan 29, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980365
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.