Clearance Summary
E-CARE INFARED EAR THERMOMETER, MODEL LCT-200 received FDA 510(k) clearance under submission number K021753, sponsored by E-Care Technology Corporation. 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 2002-08-06.
- Submission: K021753
- Applicant / Sponsor: E-Care Technology Corporation
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2002-08-06
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.