FDA 510(k)

GlucoLeader Enhance 2 Blood Glucose Monitoring System

Número K: K212248 · 2022-08-29

Data da decisão2022-08-29

Código do produtoNBW

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

GlucoLeader Enhance 2 Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Hmd Biomedical, Inc.. It received FDA 510(k) clearance on 2022-08-29 under 510(k) number K212248. 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.

Perguntas frequentes

What is the GlucoLeader Enhance 2 Blood Glucose Monitoring System?

GlucoLeader Enhance 2 Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2022-08-29. The listed applicant is Hmd Biomedical, Inc.. The 510(k) number is K212248.

When did GlucoLeader Enhance 2 Blood Glucose Monitoring System receive FDA 510(k) clearance?

GlucoLeader Enhance 2 Blood Glucose Monitoring System received FDA 510(k) clearance on 2022-08-29, under 510(k) number K212248.

Who is the listed applicant for GlucoLeader Enhance 2 Blood Glucose Monitoring System?

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

What is the FDA product code for GlucoLeader Enhance 2 Blood Glucose Monitoring System?

The FDA product code for GlucoLeader Enhance 2 Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Outros registros que listam Hmd Biomedical, Inc. como candidato(a)

K182428GlucoLeader Enhance Blood Glucose Monitoring System

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