Clearance Summary
THE INDEPENDENT CARE UNIT received FDA 510(k) clearance under submission number K893745, sponsored by The Water Carriage Co., 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 1989-09-22.
- Submission: K893745
- Applicant / Sponsor: The Water Carriage Co., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5100
- Decision date: 1989-09-22
Classification & Regulation
This clearance is catalogued under FDA product code FNL and 21 CFR 880.5100, within the General Hospital review panel as a Class II device.