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FDA 510(k)

iHealth Infrared No-Touch Forehead Thermometer

K-Number: K200531 · 2020-07-15

ApplicantAndon Health Co, Ltd.
Decision Date2020-07-15
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

iHealth Infrared No-Touch Forehead Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2020-07-15 under 510(k) number K200531. 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 iHealth Infrared No-Touch Forehead Thermometer?

iHealth Infrared No-Touch Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2020-07-15. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K200531.

When did iHealth Infrared No-Touch Forehead Thermometer receive FDA 510(k) clearance?

iHealth Infrared No-Touch Forehead Thermometer received FDA 510(k) clearance on 2020-07-15, under 510(k) number K200531.

Who is the listed applicant for iHealth Infrared No-Touch Forehead Thermometer?

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

What is the FDA product code for iHealth Infrared No-Touch Forehead Thermometer?

The FDA product code for iHealth Infrared No-Touch Forehead Thermometer is FLL.

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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