DT-100
K-Number: K160358 · 2017-02-24
ApplicantMediana Co., Ltd.
Decision Date2017-02-24
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
DT-100 is a medical device manufactured by Mediana Co., Ltd.. It received FDA 510(k) clearance on 2017-02-24 under approval number K160358. 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 DT-100?
DT-100 is a medical device that received FDA 510(k) clearance on 2017-02-24. It is manufactured by Mediana Co., Ltd.. The 510(k) number is K160358.
When was DT-100 approved by the FDA?
DT-100 received FDA 510(k) clearance on 2017-02-24, under approval number K160358.
What company makes DT-100?
DT-100 is manufactured by Mediana Co., Ltd..
What is the FDA product code for DT-100?
The FDA product code for DT-100 is FLL.
Other Devices by Mediana Co., Ltd.
Related Devices (Code: FLL)
K160306Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd.
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.
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.