Clearance Summary
HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM received FDA 510(k) clearance under submission number K122813, 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 2012-12-18.
- Submission: K122813
- Applicant / Sponsor: Cincinnati Sub-Zero Products, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4250
- Decision date: 2012-12-18
Classification & Regulation
This clearance is catalogued under FDA product code DWC and 21 CFR 870.4250, within the Cardiovascular review panel as a Class II device.