510(k) K012533 ยท DQA Oximeter
MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES
| Applicant | Osi Medical, Inc., Tampa FL, US |
| Decision | Substantially Equivalent, Aug 22, 2001 |
| Received | Aug 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012533
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.