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FDA 510(k)

EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65

K-Number: K042627 · 2004-10-18

ApplicantMesure Technology Co., Ltd.
Decision Date2004-10-18
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65 is the device name listed in this FDA 510(k) record. The listed applicant is Mesure Technology Co., Ltd.. It received FDA 510(k) clearance on 2004-10-18 under 510(k) number K042627. 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 ST61, ST62, ST63, ST64, AND ST65?

EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65 is a medical device that received FDA 510(k) clearance on 2004-10-18. The listed applicant is Mesure Technology Co., Ltd.. The 510(k) number is K042627.

When did EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65 receive FDA 510(k) clearance?

EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65 received FDA 510(k) clearance on 2004-10-18, under 510(k) number K042627.

Who is the listed applicant for EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65?

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

What is the FDA product code for EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65?

The FDA product code for EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65 is FLL.

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Other records listing Mesure 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.

K080981EAR THERMOMETER, MODELS ST66 AND ST67K071019DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIESK063542WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F.K0503035 SEC DIGITAL CLINICAL THERMOMETER, MODELS ST8630X, ST8640X, ST8730X, ST8740X, ST8930X, ST8940X, ST8030X, ST8040X.K042013DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3FK023956THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F

View all 8 devices →

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

View on FDA Database →

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

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