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FDA 510(k)

MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER

K-Number: K021601 · 2002-07-10

ApplicantDuteck Industrial Co., Ltd.
Decision Date2002-07-10
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Duteck Industrial Co., Ltd.. It received FDA 510(k) clearance on 2002-07-10 under 510(k) number K021601. 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 MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER?

MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER is a medical device that received FDA 510(k) clearance on 2002-07-10. The listed applicant is Duteck Industrial Co., Ltd.. The 510(k) number is K021601.

When did MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER receive FDA 510(k) clearance?

MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER received FDA 510(k) clearance on 2002-07-10, under 510(k) number K021601.

Who is the listed applicant for MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER?

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

What is the FDA product code for MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER?

The FDA product code for MICHEALTH ET 1100/ET 1200 INFARED EAR THERMOMETER is FLL.

Related Clinical Trials

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.

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Other records listing Duteck Industrial 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.

K060642DUTECK BODY COMPOSITION ANALYZERK992327DUTECK DIGITAL CLINICAL THERMOMETER

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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