FDA 510(k)

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

K-Number: K171822 · 2017-09-20

Decision Date2017-09-20

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05548205Effect of 2-Week Continuous Glucose Monitoring on Glycemic Management in Patients New-to-Insulin on Hospital DischargeRECRUITING NCT06657183ECM and Monitoring w/ Alio Smart Patch in Cancer Pts Receiving ChemotherapyCOMPLETED NCT07626658Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.NOT_YET_RECRUITING

Other records listing Biotest Medical Corporation as applicant

K171785WowGoHealth Blood Glucose Monitoring System

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.