FDA 510(k)

INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200

K-Number: K081788 · 2008-12-17

Decision Date2008-12-17

Product CodeFLL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200 is the device name listed in this FDA 510(k) record. The listed applicant is Innochips Technology Co., Ltd.. It received FDA 510(k) clearance on 2008-12-17 under 510(k) number K081788. 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, MODELS INNOTHERM ICT-100 AND ICT-200?

INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200 is a medical device that received FDA 510(k) clearance on 2008-12-17. The listed applicant is Innochips Technology Co., Ltd.. The 510(k) number is K081788.

When did INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200 receive FDA 510(k) clearance?

INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200 received FDA 510(k) clearance on 2008-12-17, under 510(k) number K081788.

Who is the listed applicant for INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200?

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

What is the FDA product code for INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200?

The FDA product code for INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200 is FLL.

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Other records listing Innochips Technology Co., Ltd. as applicant

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Related Devices (Code: FLL)

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.