FDA 510(k)

NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)

K-Nummer: K171822 · 2017-09-20

AntragstellerBiotest Medical Corporation

Entscheidungsdatum2017-09-20

ProduktcodeNBW

BeratungsausschussCH

EntscheidungSubstantially Equivalent

Produktübersicht

NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) is the device name listed in this FDA 510(k) record. The listed applicant is Biotest Medical Corporation. It received FDA 510(k) clearance on 2017-09-20 under 510(k) number K171822. 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.

Häufig gestellte Fragen

What is the NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)?

NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) is a medical device that received FDA 510(k) clearance on 2017-09-20. The listed applicant is Biotest Medical Corporation. The 510(k) number is K171822.

When did NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) receive FDA 510(k) clearance?

NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) received FDA 510(k) clearance on 2017-09-20, under 510(k) number K171822.

Who is the listed applicant for NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)?

The FDA 510(k) record lists Biotest Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)?

The FDA product code for NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) is NBW. This falls under the OB/GYN category.

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