Clearance Summary
SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 received FDA 510(k) clearance under submission number K073712, sponsored by Adroit Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2008-06-06.
- Submission: K073712
- Applicant / Sponsor: Adroit Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5900
- Decision date: 2008-06-06
Classification & Regulation
This clearance is catalogued under FDA product code DWJ and 21 CFR 870.5900, within the Cardiovascular review panel as a Class II device.