Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Arc Devices Limited. It received FDA 510(k) clearance on 2016-07-20 under approval 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. It is manufactured by Arc Devices Limited. The 510(k) number is K152905.

When was ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer approved by the FDA?

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

What company makes ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer?

ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer is manufactured by Arc Devices Limited.

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)

K160306Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd. K161728Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1Microfile Intellectual Property GmbH K161735Non-contact Forehead ThermometerShenzhen Dongdixin Technology Co., Ltd. K160816Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)Nexmed Technology Co., Ltd. K161211Digital ThermometerBiocare Asia Corporation , Ltd. K160802Infrared Forehead Thermometer, FT-100AHangzhou Universal Electronic 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.

↑