Clearance Summary
BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS received FDA 510(k) clearance under submission number K101589, sponsored by Cincinnati Sub-Zero Products, 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 2010-09-20.
- Submission: K101589
- Applicant / Sponsor: Cincinnati Sub-Zero Products, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5900
- Decision date: 2010-09-20
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.