Clearance Summary
NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS received FDA 510(k) clearance under submission number K120081, 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 2012-02-17.
- Submission: K120081
- 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: 2012-02-17
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.