Clearance Summary
CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND ZSET-XXX INFRARED THERMOMETER received FDA 510(k) clearance under submission number K070578, sponsored by Zen Strong Medical Technology Co., Ltd.. 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 2007-07-11.
- Submission: K070578
- Applicant / Sponsor: Zen Strong Medical Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2007-07-11
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.