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FDA 510(k)

Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11

K-Number: K203662 · 2021-09-23

ApplicantYibin Junxin Electronics Technology Co., Ltd.
Decision Date2021-09-23
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11 is the device name listed in this FDA 510(k) record. The listed applicant is Yibin Junxin Electronics Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K203662. 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, Models: YRK-002A, T8, T9, T10, T11?

Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11 is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Yibin Junxin Electronics Technology Co., Ltd.. The 510(k) number is K203662.

When did Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11 receive FDA 510(k) clearance?

Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11 received FDA 510(k) clearance on 2021-09-23, under 510(k) number K203662.

Who is the listed applicant for Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11?

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

What is the FDA product code for Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11?

The FDA product code for Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11 is FLL.

Other records listing Yibin Junxin Electronics Technology 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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