FDA 510(k)

ReliOn Premier Classic 血糖監測系統

K 號：K192220 · 2019-12-13

決定日期2019-12-13

產品代碼NBW

諮詢委員會CH

決定相當於

器材摘要

ReliOn Premier Classic Blood Glucose 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 2019-12-13 under 510(k) number K192220. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the ReliOn Premier Classic Blood Glucose Monitoring System?

ReliOn Premier Classic Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is I-Sens, Inc.. The 510(k) number is K192220.

When did ReliOn Premier Classic Blood Glucose Monitoring System receive FDA 510(k) clearance?

ReliOn Premier Classic Blood Glucose Monitoring System received FDA 510(k) clearance on 2019-12-13, under 510(k) number K192220.

Who is the listed applicant for ReliOn Premier Classic Blood Glucose 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 ReliOn Premier Classic Blood Glucose Monitoring System?

The FDA product code for ReliOn Premier Classic Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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：NBW）

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。

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官方來源

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