Clearance Summary
VDT985US Vicks SmartTemp Thermometer received FDA 510(k) clearance under submission number K152975, sponsored by Kaz USA, Inc., A Helen of Troy Company. 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 2016-03-23.
- Submission: K152975
- Applicant / Sponsor: Kaz USA, Inc., A Helen of Troy Company
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2016-03-23
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.