FDA 510(k)

KetoSens BT Blood B-Ketone Monitoring System

K-Number: K201551 · 2020-09-09

Decision Date2020-09-09

Product CodeJIN

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

KetoSens BT Blood B-Ketone Monitoring System is a medical device manufactured by I-Sens, Inc.. It received FDA 510(k) clearance on 2020-09-09 under approval number K201551. 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 BT Blood B-Ketone Monitoring System?

KetoSens BT Blood B-Ketone Monitoring System is a medical device that received FDA 510(k) clearance on 2020-09-09. It is manufactured by I-Sens, Inc.. The 510(k) number is K201551.

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

KetoSens BT Blood B-Ketone Monitoring System received FDA 510(k) clearance on 2020-09-09, under approval number K201551.

What company makes KetoSens BT Blood B-Ketone Monitoring System?

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

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

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

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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 K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemI-Sens, Inc. K192957VivaChek Blood Glucose and B-Ketone Monitoring SystemVivachek Biotech (Hangzhou) 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.