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FDA 510(k)

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

K-Number: K171822 · 2017-09-20

ApplicantBiotest Medical Corporation
Decision Date2017-09-20
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

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

When was NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) approved by the FDA?

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

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

NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) is manufactured by Biotest Medical Corporation.

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

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Related PubMed Literature

PMID: 41693672 Continuous Glucose Monitoring in Diabetes Care in Saudi Arabia: Addressing Performance Standards and Regulatory Gaps-Literature Review and Consensus Report. Journal of diabetes science and technology (2026) PMID: 41501972 First Application of an Eddy-Scale Hemolysis Model to the Food and Drug Administration Nozzle Using Computational Fluid Dynamics. ASAIO journal (American Society for Artificial Internal Organs : 1992) (2026) PMID: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025) PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024)

Other Devices by Biotest Medical Corporation

K171785WowGoHealth Blood Glucose Monitoring System

Related Devices (Code: NBW)

K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemApex BioTechnology Corp. K160742NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc. K161834One Drop Blood Glucose Monitoring SystemAgamatrix, Inc. K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring SystemsTaidoc Technology Corporation K160365BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring SystemInfopia Co, Ltd.

Official Source

View on FDA Database →

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

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