FDA 510(k)

NoCoding1 Plus 適用醫療設備規範系統，VeraSens 適用醫療設備血糖監測系統

K 號：K171480 · 2017-12-13

決定日期2017-12-13

產品代碼NBW

諮詢委員會CH

決定相當於

器材摘要

NoCoding1 Plus Blood Glucose Monitoring System, VeraSens 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 2017-12-13 under 510(k) number K171480. 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 NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System?

NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2017-12-13. The listed applicant is I-Sens, Inc.. The 510(k) number is K171480.

When did NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System receive FDA 510(k) clearance?

NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System received FDA 510(k) clearance on 2017-12-13, under 510(k) number K171480.

Who is the listed applicant for NoCoding1 Plus Blood Glucose Monitoring System, VeraSens 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 NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System?

The FDA product code for NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.