Clearance Summary
E-CARE INFRARED EAR THERMOMETER received FDA 510(k) clearance under submission number K113095, 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 2012-03-02.
- Submission: K113095
- 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: 2012-03-02
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.