Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Cloud Smart Thermometer

K-Number: K160306 · 2016-12-13

ApplicantGuangzhou Bosma Technology Co, Ltd.
Decision Date2016-12-13
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Cloud Smart Thermometer is a medical device manufactured by Guangzhou Bosma Technology Co, Ltd.. It received FDA 510(k) clearance on 2016-12-13 under approval number K160306. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cloud Smart Thermometer?

Cloud Smart Thermometer is a medical device that received FDA 510(k) clearance on 2016-12-13. It is manufactured by Guangzhou Bosma Technology Co, Ltd.. The 510(k) number is K160306.

When was Cloud Smart Thermometer approved by the FDA?

Cloud Smart Thermometer received FDA 510(k) clearance on 2016-12-13, under approval number K160306.

What company makes Cloud Smart Thermometer?

Cloud Smart Thermometer is manufactured by Guangzhou Bosma Technology Co, Ltd..

What is the FDA product code for Cloud Smart Thermometer?

The FDA product code for Cloud Smart Thermometer is FLL.

Related Devices (Code: FLL)

K161728Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1Microfile Intellectual Property GmbH K161735Non-contact Forehead ThermometerShenzhen Dongdixin Technology Co., Ltd. K160816Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)Nexmed Technology Co., Ltd. K161211Digital ThermometerBiocare Asia Corporation , Ltd. K160802Infrared Forehead Thermometer, FT-100AHangzhou Universal Electronic Co., Ltd. K161933The Braun ThermoScan® 3 High Speed Compact Ear ThermometerKaz USA, Inc., A Helen of Troy Company

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑