FDA 510(k)

RIGHTEST 血糖監測系統 Max Tel

K 號：K231192 · 2024-01-19

決定日期2024-01-19

產品代碼NBW

諮詢委員會CH

決定相當於

器材摘要

RIGHTEST Blood Glucose Monitoring System Max Tel is the device name listed in this FDA 510(k) record. The listed applicant is Bionime Corporation. It received FDA 510(k) clearance on 2024-01-19 under 510(k) number K231192. 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 RIGHTEST Blood Glucose Monitoring System Max Tel?

RIGHTEST Blood Glucose Monitoring System Max Tel is a medical device that received FDA 510(k) clearance on 2024-01-19. The listed applicant is Bionime Corporation. The 510(k) number is K231192.

When did RIGHTEST Blood Glucose Monitoring System Max Tel receive FDA 510(k) clearance?

RIGHTEST Blood Glucose Monitoring System Max Tel received FDA 510(k) clearance on 2024-01-19, under 510(k) number K231192.

Who is the listed applicant for RIGHTEST Blood Glucose Monitoring System Max Tel?

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

What is the FDA product code for RIGHTEST Blood Glucose Monitoring System Max Tel?

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

其他以 Bionime Corporation 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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