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FDA 510(k)

INFRARED BODY THERMOMETER (Model: YK-001)

K-Number: K210118 · 2021-09-15

ApplicantLongnan Renzhong Medical Equipment Co., Ltd.
Decision Date2021-09-15
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFRARED BODY THERMOMETER (Model: YK-001) is the device name listed in this FDA 510(k) record. The listed applicant is Longnan Renzhong Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-09-15 under 510(k) number K210118. 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 BODY THERMOMETER (Model: YK-001)?

INFRARED BODY THERMOMETER (Model: YK-001) is a medical device that received FDA 510(k) clearance on 2021-09-15. The listed applicant is Longnan Renzhong Medical Equipment Co., Ltd.. The 510(k) number is K210118.

When did INFRARED BODY THERMOMETER (Model: YK-001) receive FDA 510(k) clearance?

INFRARED BODY THERMOMETER (Model: YK-001) received FDA 510(k) clearance on 2021-09-15, under 510(k) number K210118.

Who is the listed applicant for INFRARED BODY THERMOMETER (Model: YK-001)?

The FDA 510(k) record lists Longnan Renzhong Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFRARED BODY THERMOMETER (Model: YK-001)?

The FDA product code for INFRARED BODY THERMOMETER (Model: YK-001) is FLL.

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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