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FDA 510(k)

DeRoyal Temperature Monitoring Probe

K-Number: K200631 · 2020-12-23

ApplicantDeroyal Industries, Inc.
Decision Date2020-12-23
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DeRoyal Temperature Monitoring Probe is a medical device manufactured by Deroyal Industries, Inc.. It received FDA 510(k) clearance on 2020-12-23 under approval number K200631. 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 DeRoyal Temperature Monitoring Probe?

DeRoyal Temperature Monitoring Probe is a medical device that received FDA 510(k) clearance on 2020-12-23. It is manufactured by Deroyal Industries, Inc.. The 510(k) number is K200631.

When was DeRoyal Temperature Monitoring Probe approved by the FDA?

DeRoyal Temperature Monitoring Probe received FDA 510(k) clearance on 2020-12-23, under approval number K200631.

What company makes DeRoyal Temperature Monitoring Probe?

DeRoyal Temperature Monitoring Probe is manufactured by Deroyal Industries, Inc..

What is the FDA product code for DeRoyal Temperature Monitoring Probe?

The FDA product code for DeRoyal Temperature Monitoring Probe is FLL.

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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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