Clearance Summary
WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H) received FDA 510(k) clearance under submission number K100226, sponsored by Rio Flexon Technology Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2010-03-18.
- Submission: K100226
- Applicant / Sponsor: Rio Flexon Technology Co., Ltd.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2010-03-18
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.