Clearance Summary
DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES received FDA 510(k) clearance under submission number K070339, sponsored by Cincinnati Sub-Zero Products, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2007-09-26.
- Submission: K070339
- Applicant / Sponsor: Cincinnati Sub-Zero Products, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2007-09-26
Classification & Regulation
This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.