Clearance Summary
HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II received FDA 510(k) clearance under submission number K012715, 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 2003-08-01.
- Submission: K012715
- Applicant / Sponsor: Hygia Health Services, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2700
- Decision date: 2003-08-01
Classification & Regulation
This clearance is catalogued under FDA product code NLF and 21 CFR 870.2700, within the Cardiovascular review panel as a Class II device.