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FDA 510(k)

INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000

K-Number: K100660 · 2010-10-22

ApplicantInnochips Technology Co., Ltd.
Decision Date2010-10-22
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000 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 2010-10-22 under 510(k) number K100660. 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 DR. SCHVEN ICT-1000?

INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000 is a medical device that received FDA 510(k) clearance on 2010-10-22. The listed applicant is Innochips Technology Co., Ltd.. The 510(k) number is K100660.

When did INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000 receive FDA 510(k) clearance?

INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000 received FDA 510(k) clearance on 2010-10-22, under 510(k) number K100660.

Who is the listed applicant for INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000?

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 MODEL DR. SCHVEN ICT-1000?

The FDA product code for INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000 is FLL.

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Other records listing Innochips 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.

K081788INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200

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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