FDA 510(k)

POGO自動血糖監測系統

K 號：K162203 · 2017-04-06

決定日期2017-04-06

產品代碼NBW

諮詢委員會CH

決定相當於

器材摘要

POGO Automatic Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Intuity Medical, Inc.. It received FDA 510(k) clearance on 2017-04-06 under 510(k) number K162203. 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 POGO Automatic Blood Glucose Monitoring System?

POGO Automatic Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2017-04-06. The listed applicant is Intuity Medical, Inc.. The 510(k) number is K162203.

When did POGO Automatic Blood Glucose Monitoring System receive FDA 510(k) clearance?

POGO Automatic Blood Glucose Monitoring System received FDA 510(k) clearance on 2017-04-06, under 510(k) number K162203.

Who is the listed applicant for POGO Automatic Blood Glucose Monitoring System?

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

What is the FDA product code for POGO Automatic Blood Glucose Monitoring System?

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

其他以 Intuity Medical, Inc. 為申請人之記錄

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K181316POGO自動血糖監測系統 K152493POGO自動血糖監測系統

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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