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FDA 510(k)

Temperature Probe

K-Number: K173194 · 2018-10-10

ApplicantOrantech, Inc.
Decision Date2018-10-10
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Temperature Probe is a medical device manufactured by Orantech, Inc.. It received FDA 510(k) clearance on 2018-10-10 under approval number K173194. 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 Temperature Probe?

Temperature Probe is a medical device that received FDA 510(k) clearance on 2018-10-10. It is manufactured by Orantech, Inc.. The 510(k) number is K173194.

When was Temperature Probe approved by the FDA?

Temperature Probe received FDA 510(k) clearance on 2018-10-10, under approval number K173194.

What company makes Temperature Probe?

Temperature Probe is manufactured by Orantech, Inc..

What is the FDA product code for Temperature Probe?

The FDA product code for Temperature Probe is FLL.

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Other Devices by Orantech, Inc.

K181270Disposable SpO2 Sensors, Reusable SpO2 Sensors K173197Reusable NIBP Cuff K171828ETCO2 Sensor K182327Patient Cables and Leadwires , Disposable ECG Leadwires

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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