FDA 510(k)

CareSens N Feliz 血糖監測系統，CareSens N Feliz BT 血糖監測系統

K 號：K201394 · 2021-10-05

決定日期2021-10-05

產品代碼NBW

諮詢委員會CH

決定相當於

器材摘要

CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is I-Sens, Inc.. It received FDA 510(k) clearance on 2021-10-05 under 510(k) number K201394. 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 CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System?

CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2021-10-05. The listed applicant is I-Sens, Inc.. The 510(k) number is K201394.

When did CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System receive FDA 510(k) clearance?

CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System received FDA 510(k) clearance on 2021-10-05, under 510(k) number K201394.

Who is the listed applicant for CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System?

The FDA 510(k) record lists I-Sens, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System?

The FDA product code for CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.