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FDA 510(k)

KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System

K-Number: K170463 · 2018-04-13

ApplicantI-Sens, Inc.
Decision Date2018-04-13
Product CodeJIN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System is a medical device manufactured by I-Sens, Inc.. It received FDA 510(k) clearance on 2018-04-13 under approval number K170463. The device is classified under product code JIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System?

KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System is a medical device that received FDA 510(k) clearance on 2018-04-13. It is manufactured by I-Sens, Inc.. The 510(k) number is K170463.

When was KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System approved by the FDA?

KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System received FDA 510(k) clearance on 2018-04-13, under approval number K170463.

What company makes KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System?

KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System is manufactured by I-Sens, Inc..

What is the FDA product code for KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System?

The FDA product code for KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System is JIN.

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Related PubMed Literature

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: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025) PMID: 37948287 TCCC Decision Support With Machine Learning Prediction of Hemorrhage Risk, Shock Probability. Military medicine (2023) PMID: 37272495 An Empirical Review of Key Glucose Monitoring Devices: Product Iterations and Patent Protection. Journal of diabetes science and technology (2025)

Other Devices by I-Sens, Inc.

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Related Devices (Code: JIN)

K170587On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for UrinalysisACON Laboratories, Inc. K182593KET-1 Blood Ketone Monitoring SystemApex BioTechnology Corp. K173345TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemTaidoc Technology Corporation K201551KetoSens BT Blood B-Ketone Monitoring SystemI-Sens, Inc. K192957VivaChek Blood Glucose and B-Ketone Monitoring SystemVivachek Biotech (Hangzhou) 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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