Clearance Summary
MODEL TI500 ISOLETTE INFANT INCUBATOR received FDA 510(k) clearance under submission number K941106, sponsored by Air-Shields, 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 1994-06-10.
- Submission: K941106
- Applicant / Sponsor: Air-Shields, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5410
- Decision date: 1994-06-10
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.