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Model DS-1901 Digital Blood Pressure Monitor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K050697

by Nihon Seimitsu Sokki Co., Ltd.

Identifiers

510(k) Number
K050697 FDA 510(k)
FDA Product Code
DXN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1130 FDA 510(k)
Regulation Number
870.1130 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Model DS-1901 Digital Blood Pressure Monitor is an automatic sphygmomanometer intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adult patients, i.e., age 12 and above. It is designed for use in a homecare environment as an adjunct to medical management, particularly for patients with labile blood pressure or known hypertension.

The device is supplied as a reusable system for self-measurement by the patient or caregiver. It operates in a non-sterile, ambient environment and is not intended for MRI use. Authorization is based on FDA 510(k) clearance under product code DXN, with decision date 2005-03-25 and K-number K050697.

Frequently asked questions

What is the Model DS-1901 Digital Blood Pressure Monitor used for?

It is intended for the noninvasive measurement of systolic and diastolic blood pressure and determination of pulse rate in adult patients aged 12 and above, serving as an adjunct to medical management for patients with labile blood pressure or known hypertension in a homecare environment.

How is the Model DS-1901 supplied and intended to be used?

The device is supplied as a reusable system for self-measurement by the patient or caregiver, designed for use in a non-sterile, ambient homecare setting and not intended for MRI use.

What regulatory pathway was used for the Model DS-1901 Digital Blood Pressure Monitor?

Authorization is based on FDA 510(k) clearance under product code DXN, with a decision date of 2005-03-25 and K-number K050697, indicating it was found substantially equivalent to a predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Modification To: Digital Blood Pressure Monitor, Model 1901, [PDF] MAY - 9 2008 - accessdata.fda.gov, PDF MAR 2 5 2005 - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nihon Seimitsu Sokki Co., Ltd.

Sources (1)

  • FDA 510(k) K050697 24 fields · synced Oct 6, 2026