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FDA 510(k)

YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02

K-Number: K102508 · 2011-01-10

ApplicantYu Long Sheng Technology Co., Ltd.
Decision Date2011-01-10
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02 is the device name listed in this FDA 510(k) record. The listed applicant is Yu Long Sheng Technology Co., Ltd.. It received FDA 510(k) clearance on 2011-01-10 under 510(k) number K102508. 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 YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02?

YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02 is a medical device that received FDA 510(k) clearance on 2011-01-10. The listed applicant is Yu Long Sheng Technology Co., Ltd.. The 510(k) number is K102508.

When did YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02 receive FDA 510(k) clearance?

YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02 received FDA 510(k) clearance on 2011-01-10, under 510(k) number K102508.

Who is the listed applicant for YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02?

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

What is the FDA product code for YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02?

The FDA product code for YU LONG SHENG DISPOSABLE THERMOMETER SHEATHS, MODELS YLS-01 AND YLS-02 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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