Clearance Summary
INFANT CARE SYSTEM received FDA 510(k) clearance under submission number K790137, 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 1979-03-06.
- Submission: K790137
- Applicant / Sponsor: Narco Air-Shields
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5130
- Decision date: 1979-03-06
Classification & Regulation
This clearance is catalogued under FDA product code FMT and 21 CFR 880.5130, within the General Hospital review panel as a Class II device.