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FDA 510(k)

Radius T wearable thermometer

K-Number: K203215 · 2021-06-11

ApplicantMasimo Corporation
Decision Date2021-06-11
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Radius T wearable thermometer is a medical device manufactured by Masimo Corporation. It received FDA 510(k) clearance on 2021-06-11 under approval number K203215. 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 Radius T wearable thermometer?

Radius T wearable thermometer is a medical device that received FDA 510(k) clearance on 2021-06-11. It is manufactured by Masimo Corporation. The 510(k) number is K203215.

When was Radius T wearable thermometer approved by the FDA?

Radius T wearable thermometer received FDA 510(k) clearance on 2021-06-11, under approval number K203215.

What company makes Radius T wearable thermometer?

Radius T wearable thermometer is manufactured by Masimo Corporation.

What is the FDA product code for Radius T wearable thermometer?

The FDA product code for Radius T wearable thermometer is FLL.

Related Clinical Trials

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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.

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