Clearance Summary
TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX received FDA 510(k) clearance under submission number K010235, sponsored by Oriental System Technology, Inc.. 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 2001-07-09.
- Submission: K010235
- Applicant / Sponsor: Oriental System Technology, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2001-07-09
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.