Clearance Summary
TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370 received FDA 510(k) clearance under submission number K090564, sponsored by Truly Instrument Limited. 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 2009-06-24.
- Submission: K090564
- Applicant / Sponsor: Truly Instrument Limited
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2009-06-24
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.