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Siemens Np Noninvasive Blood Press Measurement Sys

by Siemens Medical Electronics

510(k) K914765

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK914765 Date6 Nov 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Siemens NP Noninvasive Blood Pressure Measurement System is a system, measurement, blood-pressure, noninvasive device, classified under FDA regulation 870.1130. It is designed to measure systolic, diastolic, and mean arterial blood pressure noninvasively by utilizing transducers applied to the surface of the body. This device provides real-time pressure readings without the need for invasive procedures, facilitating cardiovascular monitoring and assessment.

This system is intended for use in clinical and home settings for blood pressure measurement. It is supplied as a reusable medical device and has received FDA 510(k) clearance under the traditional pathway, with a clearance number of K914765. The device falls under FDA Class II classification and is regulated under the Cardiovascular specialty. No specific sterility or MRI safety information is provided in the available data.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Siemens NP Noninvasive Blood Pressure Measurement System used for?

    It is designed to measure systolic, diastolic, and mean arterial blood pressure noninvasively by utilizing transducers applied to the surface of the body, facilitating cardiovascular monitoring and assessment in clinical and home settings.

  • How is the Siemens NP Noninvasive Blood Pressure Measurement System supplied and intended for use?

    The device is supplied as a reusable medical device intended for repeated use in both clinical and home environments for blood pressure measurement without invasive procedures.

  • Does the Siemens NP Noninvasive Blood Pressure Measurement System require sterility or have MRI safety information?

    No specific sterility or MRI safety information is provided in the available data for this device, so users should consult the manufacturer's labeling for detailed safety and handling instructions.