FDA 510(k)

GAL-1A Plus 適用醫療設備監管系統

K 號：K213887 · 2022-03-29

決定日期2022-03-29

產品代碼NBW

諮詢委員會CH

決定相當於

器材摘要

GAL-1A Plus Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2022-03-29 under 510(k) number K213887. 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 GAL-1A Plus Blood Glucose Monitoring System?

GAL-1A Plus Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2022-03-29. The listed applicant is Apex BioTechnology Corp.. The 510(k) number is K213887.

When did GAL-1A Plus Blood Glucose Monitoring System receive FDA 510(k) clearance?

GAL-1A Plus Blood Glucose Monitoring System received FDA 510(k) clearance on 2022-03-29, under 510(k) number K213887.

Who is the listed applicant for GAL-1A Plus Blood Glucose Monitoring System?

The FDA 510(k) record lists Apex BioTechnology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAL-1A Plus Blood Glucose Monitoring System?

The FDA product code for GAL-1A Plus Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

其他以 Apex BioTechnology Corp. 為申請人之記錄

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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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