Clearance Summary
CLEAR (TM) SPECIAL NIT COMB received FDA 510(k) clearance under submission number K981037, sponsored by Care Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1998-05-22.
- Submission: K981037
- Applicant / Sponsor: Care Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5960
- Decision date: 1998-05-22
Classification & Regulation
This clearance is catalogued under FDA product code LJL and 21 CFR 880.5960, within the General Hospital review panel as a Class I device.