Clearance Summary
TRANSPORT INCUBATOR received FDA 510(k) clearance under submission number K790551, sponsored by Narco Air-Shields. 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 1979-04-24.
- Submission: K790551
- Applicant / Sponsor: Narco Air-Shields
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5410
- Decision date: 1979-04-24
Classification & Regulation
This clearance is catalogued under FDA product code FPL and 21 CFR 880.5410, within the General Hospital review panel as a Class II device.