510(k) K970365 ยท JOH Tube Tracheostomy And Tube Cuff
PASSY-MUIR O2 ADAPTER; PMA2000
| Applicant | Passy-Muir, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 12, 1997 |
| Received | Jan 31, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970365
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.