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FDA 510(k)

INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22

K-Number: K063291 · 2006-11-21

ApplicantChoice Smart Health Care Co. , Ltd.
Decision Date2006-11-21
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22 is the device name listed in this FDA 510(k) record. The listed applicant is Choice Smart Health Care Co. , Ltd.. It received FDA 510(k) clearance on 2006-11-21 under 510(k) number K063291. 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 INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22?

INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22 is a medical device that received FDA 510(k) clearance on 2006-11-21. The listed applicant is Choice Smart Health Care Co. , Ltd.. The 510(k) number is K063291.

When did INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22 receive FDA 510(k) clearance?

INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22 received FDA 510(k) clearance on 2006-11-21, under 510(k) number K063291.

Who is the listed applicant for INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22?

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

What is the FDA product code for INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22?

The FDA product code for INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22 is FLL.

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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 Choice Smart Health Care 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.

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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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