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FDA 510(k)

GLB BENECHECK PREMIUM GLU MONITORING SYSTEM

K-Number: K123090 · 2013-11-22

ApplicantGeneral Life Biotechnology Co., Ltd.
Decision Date2013-11-22
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLB BENECHECK PREMIUM GLU MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is General Life Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2013-11-22 under 510(k) number K123090. 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 GLB BENECHECK PREMIUM GLU MONITORING SYSTEM?

GLB BENECHECK PREMIUM GLU MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-22. The listed applicant is General Life Biotechnology Co., Ltd.. The 510(k) number is K123090.

When did GLB BENECHECK PREMIUM GLU MONITORING SYSTEM receive FDA 510(k) clearance?

GLB BENECHECK PREMIUM GLU MONITORING SYSTEM received FDA 510(k) clearance on 2013-11-22, under 510(k) number K123090.

Who is the listed applicant for GLB BENECHECK PREMIUM GLU MONITORING SYSTEM?

The FDA 510(k) record lists General Life Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLB BENECHECK PREMIUM GLU MONITORING SYSTEM?

The FDA product code for GLB BENECHECK PREMIUM GLU MONITORING SYSTEM is NBW. This falls under the OB/GYN category.

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Related Devices (Code: NBW)

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.

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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.

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