Clearance Summary
NON-CONTACT INFRARED THERMOMETER received FDA 510(k) clearance under submission number K102947, sponsored by K-Jump Health Co., Ltd.. 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 2011-02-25.
- Submission: K102947
- Applicant / Sponsor: K-Jump Health Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2011-02-25
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.