FDA 510(k)

KetoSens 血糖B-酮體監測系統，KetoSens 多功能血B-酮體監測系統

K 號：K170463 · 2018-04-13

決定日期2018-04-13

產品代碼JIN

諮詢委員會CH

決定相當於

器材摘要

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.

常見問題

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.

其他以 I-Sens, Inc. 為申請人之記錄

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K230625ReliOn Premier BLU 血糖監測系統 K222656LDE4 穿刺器 K201394CareSens N Feliz 血糖監測系統，CareSens N Feliz BT 血糖監測系統 K201551KetoSens BT 血糖酮體監測系統 K192859CareSens S 清晰 BT 血糖監測系統 K193590CareSens S Fit BT 血糖監測系統

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相關器械（代碼：JIN）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K201551KetoSens BT 血糖酮體監測系統I-Sens, Inc.K192957VivaChek 血糖及B-酮體監測系統Vivachek Biotech (Hangzhou) Co., Ltd.K182593KET-1 血糖酮體監測系統Apex BioTechnology Corp.K173345TD-4140 智能轉接器血糖加B-酮體監測系統Taidoc Technology Corporation K170587即時酮體試劑條，用於尿液化驗；健康我酮體試劑條，用於尿液化驗ACON Laboratories, Inc.

官方來源

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