FDA 510(k)

ACCU-CHEK Système de surveillance de la glycémie en glucose

Numéro K : K160944 · 2016-08-31

Date de décision2016-08-31

Code produitNBW

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

ACCU-CHEK Guide Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diabetes Care, Inc.. It received FDA 510(k) clearance on 2016-08-31 under 510(k) number K160944. 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.

Questions fréquentes

What is the ACCU-CHEK Guide Blood Glucose Monitoring System?

ACCU-CHEK Guide Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2016-08-31. The listed applicant is Roche Diabetes Care, Inc.. The 510(k) number is K160944.

When did ACCU-CHEK Guide Blood Glucose Monitoring System receive FDA 510(k) clearance?

ACCU-CHEK Guide Blood Glucose Monitoring System received FDA 510(k) clearance on 2016-08-31, under 510(k) number K160944.

Who is the listed applicant for ACCU-CHEK Guide Blood Glucose Monitoring System?

The FDA 510(k) record lists Roche Diabetes Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCU-CHEK Guide Blood Glucose Monitoring System?

The FDA product code for ACCU-CHEK Guide Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Source officielle

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