510(k) K010388 ยท HCC Device, Biofeedback
SONDREX P.A.L. SYSTEM
| Applicant | Ohmeda Medical, Laurel MD, US |
| Decision | Substantially Equivalent, Dec 11, 2001 |
| Received | Feb 8, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010388
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.