ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA— 510(k) K100523
Substantially EquivalentHygia Health Services, Inc.
FDA 510(k) clearance K100523 for ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA, Substantially Equivalent on 2010-05-04. Applicant: Hygia Health Services, Inc..
Clearance details
- Applicant
- Hygia Health Services, Inc.
- Product code
- Code NMD
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Birmingham, AL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.