Clearance Summary
Giraffe OmniBed Carestation CS1 received FDA 510(k) clearance under submission number K152814, sponsored by Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company. 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 2016-03-17.
- Submission: K152814
- Applicant / Sponsor: Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5400
- Decision date: 2016-03-17
Classification & Regulation
This clearance is catalogued under FDA product code FMZ and 21 CFR 880.5400, within the General Hospital review panel as a Class II device.