Clearance Summary
IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081 received FDA 510(k) clearance under submission number K100488, sponsored by Shenzhen Dongdixin 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 2010-07-22.
- Submission: K100488
- Applicant / Sponsor: Shenzhen Dongdixin Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2010-07-22
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.