Clearance Summary
ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA received FDA 510(k) clearance under submission number K100523, sponsored by Hygia Health Services, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-05-04.
- Submission: K100523
- Applicant / Sponsor: Hygia Health Services, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2010-05-04
Classification & Regulation
This clearance is catalogued under FDA product code NMD and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.