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FDA 510(k)

YOUNG-HEALTH SUPER EAR THERMOMETER

K-Number: K002727 · 2001-06-13

ApplicantYoung Health Ind. Co., Ltd.
Decision Date2001-06-13
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

YOUNG-HEALTH SUPER EAR THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Young Health Ind. Co., Ltd.. It received FDA 510(k) clearance on 2001-06-13 under 510(k) number K002727. 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 YOUNG-HEALTH SUPER EAR THERMOMETER?

YOUNG-HEALTH SUPER EAR THERMOMETER is a medical device that received FDA 510(k) clearance on 2001-06-13. The listed applicant is Young Health Ind. Co., Ltd.. The 510(k) number is K002727.

When did YOUNG-HEALTH SUPER EAR THERMOMETER receive FDA 510(k) clearance?

YOUNG-HEALTH SUPER EAR THERMOMETER received FDA 510(k) clearance on 2001-06-13, under 510(k) number K002727.

Who is the listed applicant for YOUNG-HEALTH SUPER EAR THERMOMETER?

The FDA 510(k) record lists Young Health Ind. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for YOUNG-HEALTH SUPER EAR THERMOMETER?

The FDA product code for YOUNG-HEALTH SUPER EAR THERMOMETER is FLL.

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

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