Clearance Summary
C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM received FDA 510(k) clearance under submission number K912910, sponsored by Air-Shields Vickers, 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 1991-10-30.
- Submission: K912910
- Applicant / Sponsor: Air-Shields Vickers, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5400
- Decision date: 1991-10-30
Classification & Regulation
This clearance is catalogued under FDA product code FMZ and 21 CFR 880.5400, within the General Hospital review panel as a Class II device.