Clearance Summary
CRITICOOL received FDA 510(k) clearance under submission number K083662, sponsored by Mtre Advanced Technology , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2009-03-26.
- Submission: K083662
- Applicant / Sponsor: Mtre Advanced Technology , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5900
- Decision date: 2009-03-26
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.