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FDA 510(k)

Infrared Thermometer Model E127

K-Number: K201161 · 2020-10-02

ApplicantBioland Technology, Ltd.
Decision Date2020-10-02
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Thermometer Model E127 is a medical device manufactured by Bioland Technology, Ltd.. It received FDA 510(k) clearance on 2020-10-02 under approval number K201161. 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 Infrared Thermometer Model E127?

Infrared Thermometer Model E127 is a medical device that received FDA 510(k) clearance on 2020-10-02. It is manufactured by Bioland Technology, Ltd.. The 510(k) number is K201161.

When was Infrared Thermometer Model E127 approved by the FDA?

Infrared Thermometer Model E127 received FDA 510(k) clearance on 2020-10-02, under approval number K201161.

What company makes Infrared Thermometer Model E127?

Infrared Thermometer Model E127 is manufactured by Bioland Technology, Ltd..

What is the FDA product code for Infrared Thermometer Model E127?

The FDA product code for Infrared Thermometer Model E127 is FLL.

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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.

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