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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 the device name listed in this FDA 510(k) record. The listed applicant is I-Sens, Inc.. It received FDA 510(k) clearance on 2018-04-13 under 510(k) 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. The listed applicant is I-Sens, Inc.. The 510(k) number is K170463.

When did KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System receive FDA 510(k) clearance?

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

Who is the listed applicant for KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System?

The FDA 510(k) record lists I-Sens, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing I-Sens, Inc. as applicant

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Related Devices (Code: JIN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201551KetoSens BT Blood B-Ketone Monitoring SystemI-Sens, Inc.K192957VivaChek Blood Glucose and B-Ketone Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd.K182593KET-1 Blood Ketone Monitoring SystemApex BioTechnology Corp.K173345TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemTaidoc Technology CorporationK170587On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for UrinalysisACON Laboratories, Inc.

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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