Clearance Summary
GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM received FDA 510(k) clearance under submission number K050055, sponsored by Datex-Ohmeda, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2005-02-04.
- Submission: K050055
- Applicant / Sponsor: Datex-Ohmeda, Inc.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5160
- Decision date: 2005-02-04
Classification & Regulation
This clearance is catalogued under FDA product code BSZ and 21 CFR 868.5160, within the Anesthesiology review panel as a Class II device.