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FDA 510(k)

DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM

K-Number: K080853 · 2009-02-20

ApplicantGenexel-Sein, Inc.
Decision Date2009-02-20
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Genexel-Sein, Inc.. It received FDA 510(k) clearance on 2009-02-20 under 510(k) number K080853. 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 DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM?

DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM is a medical device that received FDA 510(k) clearance on 2009-02-20. The listed applicant is Genexel-Sein, Inc.. The 510(k) number is K080853.

When did DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM receive FDA 510(k) clearance?

DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM received FDA 510(k) clearance on 2009-02-20, under 510(k) number K080853.

Who is the listed applicant for DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM?

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

What is the FDA product code for DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM?

The FDA product code for DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM 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.

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Other records listing Genexel-Sein, Inc. as applicant

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.

K071523FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700 AND BP1750

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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