FDA 510(k)

Assure 鈦金屬血糖監測系統

K 號：K200788 · 2022-05-23

決定日期2022-05-23

產品代碼PZI

諮詢委員會CH

決定相當於

器材摘要

Assure Titanium Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Arkray, Inc.. It received FDA 510(k) clearance on 2022-05-23 under 510(k) number K200788. The device is classified under product code PZI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Assure Titanium Blood Glucose Monitoring System?

Assure Titanium Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2022-05-23. The listed applicant is Arkray, Inc.. The 510(k) number is K200788.

When did Assure Titanium Blood Glucose Monitoring System receive FDA 510(k) clearance?

Assure Titanium Blood Glucose Monitoring System received FDA 510(k) clearance on 2022-05-23, under 510(k) number K200788.

Who is the listed applicant for Assure Titanium Blood Glucose Monitoring System?

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

What is the FDA product code for Assure Titanium Blood Glucose Monitoring System?

The FDA product code for Assure Titanium Blood Glucose Monitoring System is PZI.

其他以 Arkray, Inc. 為申請人之記錄

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相關器械（代碼：PZI）

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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