FDA 510(k)

VivaChek 血糖及B-酮體監測系統

K 號：K192957 · 2020-06-05

申請人Vivachek Biotech (Hangzhou) Co., Ltd.

決定日期2020-06-05

產品代碼JIN

諮詢委員會CH

決定相當於

器材摘要

VivaChek Blood Glucose and B-Ketone Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Vivachek Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2020-06-05 under 510(k) number K192957. 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 VivaChek Blood Glucose and B-Ketone Monitoring System?

VivaChek Blood Glucose and B-Ketone Monitoring System is a medical device that received FDA 510(k) clearance on 2020-06-05. The listed applicant is Vivachek Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K192957.

When did VivaChek Blood Glucose and B-Ketone Monitoring System receive FDA 510(k) clearance?

VivaChek Blood Glucose and B-Ketone Monitoring System received FDA 510(k) clearance on 2020-06-05, under 510(k) number K192957.

Who is the listed applicant for VivaChek Blood Glucose and B-Ketone Monitoring System?

The FDA 510(k) record lists Vivachek Biotech (Hangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VivaChek Blood Glucose and B-Ketone Monitoring System?

The FDA product code for VivaChek Blood Glucose and B-Ketone Monitoring System is JIN.

其他以 Vivachek Biotech (Hangzhou) Co., Ltd. 為申請人之記錄

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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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。

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