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)

Digital thermometer, Model DT101, DT102

K-Number: K213746 · 2022-04-05

ApplicantGuangzhou Berrcom Medical Device Co., Ltd.
Decision Date2022-04-05
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Digital thermometer, Model DT101, DT102 is a medical device manufactured by Guangzhou Berrcom Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2022-04-05 under approval number K213746. 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 DT101, DT102?

Digital thermometer, Model DT101, DT102 is a medical device that received FDA 510(k) clearance on 2022-04-05. It is manufactured by Guangzhou Berrcom Medical Device Co., Ltd.. The 510(k) number is K213746.

When was Digital thermometer, Model DT101, DT102 approved by the FDA?

Digital thermometer, Model DT101, DT102 received FDA 510(k) clearance on 2022-04-05, under approval number K213746.

What company makes Digital thermometer, Model DT101, DT102?

Digital thermometer, Model DT101, DT102 is manufactured by Guangzhou Berrcom Medical Device Co., Ltd..

What is the FDA product code for Digital thermometer, Model DT101, DT102?

The FDA product code for Digital thermometer, Model DT101, DT102 is FLL.

Related Clinical Trials

NCT07608302 Comparison of the Predictability of Dentoalveolar Expansion With Two Clear Aligner Systems COMPLETED NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING NCT07232667 Digital Technology for Active and Healthy Ageing in Taiwan RECRUITING NCT07179146 A Comparison Of Dental Arch Analysis Using 3d Digital Scanning Versus Conventional Methods In Children COMPLETED NCT07341633 AI-Based Digital Therapeutics vs. Traditional Schroth Exercises for Adolescent Idiopathic Scoliosis ACTIVE_NOT_RECRUITING NCT07263815 EQUIP - Evaluation of Quality of Imaging on a Next-generation Total Body Pet Scan in Comparison to Conventional PET ACTIVE_NOT_RECRUITING

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) PMID: 41346994 The status quo of the development of decentralized clinical trials. Frontiers in medicine (2025) PMID: 40006413 Data Reconstruction Methods in Multi-Feature Fusion CNN Model for Enhanced Human Activity Recognition. Sensors (Basel, Switzerland) (2025)

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

K191570Infrared Thermometer Model MD-H30 K213084Ear Thermometer, Model ET005, ET008, ET009 K213079Ear Thermometer, Model ET001 K213082Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 K214077Digital Thermometer, Model: DT007, DT008

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.

↑