Clearance Summary
INCUWARMER received FDA 510(k) clearance under submission number K971366, sponsored by Hill-Rom, 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 1998-01-05.
- Submission: K971366
- Applicant / Sponsor: Hill-Rom, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5130
- Decision date: 1998-01-05
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.