510(k) K050014 ยท GLY Oximeter To Measure Hemoglobin
HEMONIR TM
| Applicant | Nir Diagnostics, Inc., North Attleboro MA, US |
| Decision | Substantially Equivalent, May 5, 2005 |
| Received | Jan 3, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050014
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.