FDA 510(k)

Fever Scout Continuous Monitoring thermometer

K-Number: K162137 · 2017-01-19

Decision Date2017-01-19

Product CodeFLL

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Fever Scout Continuous Monitoring thermometer is a medical device manufactured by VivaLNK, Inc.. It received FDA 510(k) clearance on 2017-01-19 under approval number K162137. 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 Continuous Monitoring thermometer?

Fever Scout Continuous Monitoring thermometer is a medical device that received FDA 510(k) clearance on 2017-01-19. It is manufactured by VivaLNK, Inc.. The 510(k) number is K162137.

When was Fever Scout Continuous Monitoring thermometer approved by the FDA?

Fever Scout Continuous Monitoring thermometer received FDA 510(k) clearance on 2017-01-19, under approval number K162137.

What company makes Fever Scout Continuous Monitoring thermometer?

Fever Scout Continuous Monitoring thermometer is manufactured by VivaLNK, Inc..

What is the FDA product code for Fever Scout Continuous Monitoring thermometer?

The FDA product code for Fever Scout Continuous Monitoring thermometer is FLL.

Related Clinical Trials

NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT07599982 Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes RECRUITING NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41964171 Journal of diabetes science and technology (2026) PMID: 41760572 Trends in use of continuous glucose monitors among individuals with type 2 diabetes enrolled in Medicare Advantage (2021-2023). Journal of managed care & specialty pharmacy (2026) PMID: 41693672 Continuous Glucose Monitoring in Diabetes Care in Saudi Arabia: Addressing Performance Standards and Regulatory Gaps-Literature Review and Consensus Report. Journal of diabetes science and technology (2026) PMID: 41676069 Diabetes community calls for quality standards for continuous glucose monitoring devices. The Lancet regional health. Europe (2026)

Other Devices by VivaLNK, Inc.

K181013Fever Scout 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.