FDA 510(k)

POPS! 一血糖监测系统

K号: K181588 · 2018-11-30

决定日期2018-11-30

产品代码NBW

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决定实质等同

器械摘要

POPS! one Blood Glucose 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 2018-11-30 under 510(k) number K181588. 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 POPS! one Blood Glucose Monitoring System?

POPS! one Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2018-11-30. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K181588.

When did POPS! one Blood Glucose Monitoring System receive FDA 510(k) clearance?

POPS! one Blood Glucose Monitoring System received FDA 510(k) clearance on 2018-11-30, under 510(k) number K181588.

Who is the listed applicant for POPS! one Blood Glucose 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 POPS! one Blood Glucose Monitoring System?

The FDA product code for POPS! one Blood Glucose 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。

K221349XPER技术 PREMIUM Pro 血糖监测系统 K201037FORA ADVANCED GD40 高血糖、β-酮体和胆固醇监测系统 K200946Clever 前额式体温计 / Clever 医疗前额式体温计 (型号 TD-1241)K190579TD-4183 血糖监测系统 K182934FORA P100 血压监测系统 K180863FORA NAS100 电子鼻吸器，电子鼻吸器

查看所有 17 个设备 →

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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