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FDA 510(k)

Infrared Thermometer: Model YJ600

K-Number: K232473 · 2024-02-09

ApplicantZhuhai Yueja Medical Device Technology Co., Ltd.
Decision Date2024-02-09
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Infrared Thermometer: Model YJ600 is the device name listed in this FDA 510(k) record. The listed applicant is Zhuhai Yueja Medical Device Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-09 under 510(k) number K232473. 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 YJ600?

Infrared Thermometer: Model YJ600 is a medical device that received FDA 510(k) clearance on 2024-02-09. The listed applicant is Zhuhai Yueja Medical Device Technology Co., Ltd.. The 510(k) number is K232473.

When did Infrared Thermometer: Model YJ600 receive FDA 510(k) clearance?

Infrared Thermometer: Model YJ600 received FDA 510(k) clearance on 2024-02-09, under 510(k) number K232473.

Who is the listed applicant for Infrared Thermometer: Model YJ600?

The FDA 510(k) record lists Zhuhai Yueja Medical Device Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Thermometer: Model YJ600?

The FDA product code for Infrared Thermometer: Model YJ600 is FLL.

Other records listing Zhuhai Yueja Medical Device 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.

K232815Wrist Blood Pressure MonitorK232814Electronic Blood Pressure Monitor

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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