Clearance Summary
SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405) received FDA 510(k) clearance under submission number K062784, sponsored by Sejoy Electronics & Instruments Co., Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2007-05-04.
- Submission: K062784
- Applicant / Sponsor: Sejoy Electronics & Instruments Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2007-05-04
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.