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FDA 510(k)

Digital Thermometer, Model: DT007, DT008

K-Number: K214077 · 2023-01-20

ApplicantGuangzhou Berrcom Medical Device Co., Ltd.
Decision Date2023-01-20
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Digital Thermometer, Model: DT007, DT008 is a medical device manufactured by Guangzhou Berrcom Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2023-01-20 under approval number K214077. 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 Digital Thermometer, Model: DT007, DT008?

Digital Thermometer, Model: DT007, DT008 is a medical device that received FDA 510(k) clearance on 2023-01-20. It is manufactured by Guangzhou Berrcom Medical Device Co., Ltd.. The 510(k) number is K214077.

When was Digital Thermometer, Model: DT007, DT008 approved by the FDA?

Digital Thermometer, Model: DT007, DT008 received FDA 510(k) clearance on 2023-01-20, under approval number K214077.

What company makes Digital Thermometer, Model: DT007, DT008?

Digital Thermometer, Model: DT007, DT008 is manufactured by Guangzhou Berrcom Medical Device Co., Ltd..

What is the FDA product code for Digital Thermometer, Model: DT007, DT008?

The FDA product code for Digital Thermometer, Model: DT007, DT008 is FLL.

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Related PubMed Literature

PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026)

Other Devices by Guangzhou Berrcom Medical Device Co., Ltd.

K191570Infrared Thermometer Model MD-H30 K213746Digital thermometer, Model DT101, DT102 K213084Ear Thermometer, Model ET005, ET008, ET009 K213079Ear Thermometer, Model ET001 K213082Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311

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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