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FDA 510(k)

DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR

K-Number: K952494 · 1995-12-28

ApplicantNihon Seimitsu Sokki Co., Ltd.
Decision Date1995-12-28
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR 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 1995-12-28 under 510(k) number K952494. 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 DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR?

DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 1995-12-28. The listed applicant is Nihon Seimitsu Sokki Co., Ltd.. The 510(k) number is K952494.

When did DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR receive FDA 510(k) clearance?

DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR received FDA 510(k) clearance on 1995-12-28, under 510(k) number K952494.

Who is the listed applicant for DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR?

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 DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR?

The FDA product code for DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR is DXN.

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Other records listing Nihon Seimitsu Sokki Co., Ltd. as applicant

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K112620DISITAL BLOOD PRESSURE MONITORK112691BLOOD PRESSURE MONITORK112690BLOOD PRESSURE MONITORK093102AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-270K080177WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PVK071596POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7

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Related Devices (Code: DXN)

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

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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