FDA 510(k)

FORA ADVANCED GD40 高血糖、β-酮体和胆固醇监测系统

K号: K201037 · 2022-06-16

决定日期2022-06-16

产品代码NBW

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决定实质等同

器械摘要

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Taidoc Technology Corporation. It received FDA 510(k) clearance on 2022-06-16 under 510(k) number K201037. 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.

常见问题

What is the FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System?

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System is a medical device that received FDA 510(k) clearance on 2022-06-16. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K201037.

When did FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System receive FDA 510(k) clearance?

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System received FDA 510(k) clearance on 2022-06-16, under 510(k) number K201037.

Who is the listed applicant for FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System?

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

What is the FDA product code for FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System?

The FDA product code for FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System is NBW. This falls under the OB/GYN category.

列明Taidoc Technology Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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相关器械（代码：NBW）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260545CONTOUR® PLUS BLUE 血糖监测系统；CONTOUR® NEXT GEN 血糖监测系统；CONTOUR® NEXT ONE 血糖监测系统Ascensia Diabetes Care K262116TRUE METRIX 自监测血糖系统Trividia Health, Inc.K250085On Call® Sure GK 血糖 & 酮体监测系统；On Call® Sure Sync GK 血糖 & 酮体监测系统ACON Laboratories, Inc.K243060TeleRPM Gen2 血糖监测系统Guangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST 血糖监测系统 Max TelBionime Corporation K240640Sejoy 血糖监测系统；Sejoy 先进链接血糖监测系统Sejoy Biomedical Co., Ltd.

官方来源

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