510(k) K100523 ยท NMD Oximeter, Tissue Saturation, Reprocessed
ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA
| Applicant | Hygia Health Services, Inc., Birmingham AL, US |
| Decision | Substantially Equivalent, May 4, 2010 |
| Received | Feb 24, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100523
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.