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FDA 510(k)

AT-6XX Series Infrared Thermometer

K-Number: K171455 · 2018-02-09

ApplicantXiamen Acurio Instruments Co., Ltd.
Decision Date2018-02-09
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AT-6XX Series Infrared Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Acurio Instruments Co., Ltd.. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K171455. 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 AT-6XX Series Infrared Thermometer?

AT-6XX Series Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Xiamen Acurio Instruments Co., Ltd.. The 510(k) number is K171455.

When did AT-6XX Series Infrared Thermometer receive FDA 510(k) clearance?

AT-6XX Series Infrared Thermometer received FDA 510(k) clearance on 2018-02-09, under 510(k) number K171455.

Who is the listed applicant for AT-6XX Series Infrared Thermometer?

The FDA 510(k) record lists Xiamen Acurio Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AT-6XX Series Infrared Thermometer?

The FDA product code for AT-6XX Series Infrared Thermometer is FLL.

Other records listing Xiamen Acurio Instruments Co., 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.

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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

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