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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 the device name listed in this FDA 510(k) record. The listed applicant is Bioland Technology, Ltd.. It received FDA 510(k) clearance on 2020-10-02 under 510(k) 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. The listed applicant is Bioland Technology, Ltd.. The 510(k) number is K201161.

When did Infrared Thermometer Model E127 receive FDA 510(k) clearance?

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

Who is the listed applicant for Infrared Thermometer Model E127?

The FDA 510(k) record lists Bioland Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Bioland Technology, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202739Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring SystemK213011Infrared Thermometer (model: E201)K201879Digital Thermometer Model T103, T104K202934Blood Pressure MonitorK201467Blood Pressure Monitor-Model 2005, 2006-2, 2006-2BK191657Bioland Blood Glucose Monitoring System

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Related Devices (Code: FLL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082Infrared ThermometerGuangzhou Daxin Health Technology 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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