FDA 510(k)

SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100

K-Number: K052108 · 2005-12-07

Decision Date2005-12-07

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 is the device name listed in this FDA 510(k) record. The listed applicant is Sein Electronics Co., Ltd.. It received FDA 510(k) clearance on 2005-12-07 under 510(k) number K052108. 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 SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100?

SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 is a medical device that received FDA 510(k) clearance on 2005-12-07. The listed applicant is Sein Electronics Co., Ltd.. The 510(k) number is K052108.

When did SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 receive FDA 510(k) clearance?

SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 received FDA 510(k) clearance on 2005-12-07, under 510(k) number K052108.

Who is the listed applicant for SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100?

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

What is the FDA product code for SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100?

The FDA product code for SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 is NBW. This falls under the OB/GYN category.

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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.