Clearance Summary
Infrared Thermometer Model Number RN-60A,RN-60B received FDA 510(k) clearance under submission number K200471, sponsored by Ningbo Ranor Medical Science & Technology 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 2020-06-19.
- Submission: K200471
- Applicant / Sponsor: Ningbo Ranor Medical Science & Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2020-06-19
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.