Clearance Summary
JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001 received FDA 510(k) clearance under submission number K101322, sponsored by Joinsoon Electronics Mfg 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 2010-07-28.
- Submission: K101322
- Applicant / Sponsor: Joinsoon Electronics Mfg Co, Ltd.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2010-07-28
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.