FDA 510(k)

Fever Scout

K-Number: K181013 · 2018-08-21

Decision Date2018-08-21

Product CodeFLL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Fever Scout is a medical device manufactured by VivaLNK, Inc.. It received FDA 510(k) clearance on 2018-08-21 under approval number K181013. 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 Fever Scout?

Fever Scout is a medical device that received FDA 510(k) clearance on 2018-08-21. It is manufactured by VivaLNK, Inc.. The 510(k) number is K181013.

When was Fever Scout approved by the FDA?

Fever Scout received FDA 510(k) clearance on 2018-08-21, under approval number K181013.

What company makes Fever Scout?

Fever Scout is manufactured by VivaLNK, Inc..

What is the FDA product code for Fever Scout?

The FDA product code for Fever Scout is FLL.

Other Devices by VivaLNK, Inc.

K162137Fever Scout Continuous Monitoring thermometer K191870VV330 Continuous ECG Platform, VivaLNK Adhesive Patch

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.