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FDA 510(k)

MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR

K-Number: K050697 · 2005-03-25

ApplicantNihon Seimitsu Sokki Co., Ltd.
Decision Date2005-03-25
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL DS-1901 DIGITAL 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 2005-03-25 under 510(k) number K050697. 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 MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR?

MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 2005-03-25. The listed applicant is Nihon Seimitsu Sokki Co., Ltd.. The 510(k) number is K050697.

When did MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR receive FDA 510(k) clearance?

MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR received FDA 510(k) clearance on 2005-03-25, under 510(k) number K050697.

Who is the listed applicant for MODEL DS-1901 DIGITAL 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 MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR?

The FDA product code for MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR is DXN.

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

K112620DISITAL BLOOD PRESSURE MONITORK112690BLOOD PRESSURE MONITORK112691BLOOD 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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