Clearance Summary
EVEREST & JENNINGS BED MODEL NO. L109564 & L108564 received FDA 510(k) clearance under submission number K854776, sponsored by Carrom 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 1985-12-13.
- Submission: K854776
- Applicant / Sponsor: Carrom Healthcare, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5120
- Decision date: 1985-12-13
Classification & Regulation
This clearance is catalogued under FDA product code FNJ and 21 CFR 880.5120, within the General Hospital review panel as a Class I device.