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FDA 510(k)

EAR THERMOMETER, MODELS ST613C AND ST613F

K-Number: K011254 · 2001-07-10

ApplicantMesure Technology
Decision Date2001-07-10
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EAR THERMOMETER, MODELS ST613C AND ST613F is the device name listed in this FDA 510(k) record. The listed applicant is Mesure Technology. It received FDA 510(k) clearance on 2001-07-10 under 510(k) number K011254. 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 EAR THERMOMETER, MODELS ST613C AND ST613F?

EAR THERMOMETER, MODELS ST613C AND ST613F is a medical device that received FDA 510(k) clearance on 2001-07-10. The listed applicant is Mesure Technology. The 510(k) number is K011254.

When did EAR THERMOMETER, MODELS ST613C AND ST613F receive FDA 510(k) clearance?

EAR THERMOMETER, MODELS ST613C AND ST613F received FDA 510(k) clearance on 2001-07-10, under 510(k) number K011254.

Who is the listed applicant for EAR THERMOMETER, MODELS ST613C AND ST613F?

The FDA 510(k) record lists Mesure Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EAR THERMOMETER, MODELS ST613C AND ST613F?

The FDA product code for EAR THERMOMETER, MODELS ST613C AND ST613F is FLL.

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Other records listing Mesure Technology 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.

K013779THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542FK011585FAST THERMOMETER MODELS ST713C AND ST713FK981337DIGITAL CLINICAL THERMOMETER, MODELS ST-833A & ST-834AK962520DIGITAL CLINICAL THERMOMETER ST-813A, ST-814A, ST-823 AND ST-823A

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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