Clearance Summary
GIRAFFE AND PANDA WARMERS received FDA 510(k) clearance under submission number K101804, sponsored by Ohmeda Medical, A Division of Datex-Ohmeda, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2010-07-21.
- Submission: K101804
- Applicant / Sponsor: Ohmeda Medical, A Division of Datex-Ohmeda, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5130
- Decision date: 2010-07-21
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.