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FDA 510(k)

INFRARED EAR THEROMETER

K-Number: K111703 · 2012-03-29

ApplicantFudakang Industrial Co., Ltd.
Decision Date2012-03-29
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFRARED EAR THEROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Fudakang Industrial Co., Ltd.. It received FDA 510(k) clearance on 2012-03-29 under 510(k) number K111703. 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 THEROMETER?

INFRARED EAR THEROMETER is a medical device that received FDA 510(k) clearance on 2012-03-29. The listed applicant is Fudakang Industrial Co., Ltd.. The 510(k) number is K111703.

When did INFRARED EAR THEROMETER receive FDA 510(k) clearance?

INFRARED EAR THEROMETER received FDA 510(k) clearance on 2012-03-29, under 510(k) number K111703.

Who is the listed applicant for INFRARED EAR THEROMETER?

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

What is the FDA product code for INFRARED EAR THEROMETER?

The FDA product code for INFRARED EAR THEROMETER is FLL.

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Other records listing Fudakang 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.

K172121Digital ThermometerK160308Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)

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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