Clearance Summary
OHMEDA 7800 ANESTHESIA VENTILATOR received FDA 510(k) clearance under submission number K913791, sponsored by Ohmeda Anesthesia Systems Therapy Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1993-04-08.
- Submission: K913791
- Applicant / Sponsor: Ohmeda Anesthesia Systems Therapy Group
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5160
- Decision date: 1993-04-08
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.