Clearance Summary
FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO received FDA 510(k) clearance under submission number K081447, sponsored by Draeger Medical AG & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2008-10-08.
- Submission: K081447
- Applicant / Sponsor: Draeger Medical AG & Co. KG
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5160
- Decision date: 2008-10-08
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.