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FDA 510(k)

ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer

K-Number: K152905 · 2016-07-20

ApplicantArc Devices Limited
Decision Date2016-07-20
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Arc Devices Limited. It received FDA 510(k) clearance on 2016-07-20 under 510(k) number K152905. 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 ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer?

ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer is a medical device that received FDA 510(k) clearance on 2016-07-20. The listed applicant is Arc Devices Limited. The 510(k) number is K152905.

When did ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer receive FDA 510(k) clearance?

ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer received FDA 510(k) clearance on 2016-07-20, under 510(k) number K152905.

Who is the listed applicant for ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer?

The FDA 510(k) record lists Arc Devices Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer?

The FDA product code for ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer is FLL.

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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