Clearance Summary
CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED received FDA 510(k) clearance under submission number K962250, sponsored by Carroll Healthcare, 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 1996-10-21.
- Submission: K962250
- Applicant / Sponsor: Carroll Healthcare, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5100
- Decision date: 1996-10-21
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.