Clearance Summary
BASSINET STAND WITH DRESSING TRAY received FDA 510(k) clearance under submission number K880838, sponsored by Serv-Queen, 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 1988-04-29.
- Submission: K880838
- Applicant / Sponsor: Serv-Queen, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5140
- Decision date: 1988-04-29
Classification & Regulation
This clearance is catalogued under FDA product code FMS and 21 CFR 880.5140, within the General Hospital review panel as a Class II device.