510(k) K001085 ยท DQA Oximeter
MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500
| Applicant | Nonin Medical, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, May 1, 2000 |
| Received | Apr 4, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001085
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.