Clearance Summary
NEONATAL INCUBATOR (ACCESSORY) received FDA 510(k) clearance under submission number K895782, 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 1989-12-07.
- Submission: K895782
- 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: 1989-12-07
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.