Clearance Summary
FLH1768M SERIES HOSPITAL BED received FDA 510(k) clearance under submission number K930234, sponsored by Bertec Medical, 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 1993-07-27.
- Submission: K930234
- Applicant / Sponsor: Bertec Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5100
- Decision date: 1993-07-27
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.