Clearance Summary
Probe Covers for Thermometers received FDA 510(k) clearance under submission number K180714, sponsored by K-Jump Health Co., Ltd.. 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 2018-09-24.
- Submission: K180714
- Applicant / Sponsor: K-Jump Health Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2018-09-24
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.