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FDA 510(k)

WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV

K-Number: K080177 · 2008-05-09

ApplicantNihon Seimitsu Sokki Co., Ltd.
Decision Date2008-05-09
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Seimitsu Sokki Co., Ltd.. It received FDA 510(k) clearance on 2008-05-09 under 510(k) number K080177. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV?

WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV is a medical device that received FDA 510(k) clearance on 2008-05-09. The listed applicant is Nihon Seimitsu Sokki Co., Ltd.. The 510(k) number is K080177.

When did WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV receive FDA 510(k) clearance?

WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV received FDA 510(k) clearance on 2008-05-09, under 510(k) number K080177.

Who is the listed applicant for WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV?

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

What is the FDA product code for WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV?

The FDA product code for WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV is DXN.

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Related Devices (Code: DXN)

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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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