Clearance Summary
(MULTIPLE) DIGITAL THERMOMETER received FDA 510(k) clearance under submission number K120004, sponsored by China Shenyang Med-Land Imp/Exp Corp., 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 2012-08-23.
- Submission: K120004
- Applicant / Sponsor: China Shenyang Med-Land Imp/Exp Corp., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2012-08-23
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.