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Physiological Measurement and Display Systems

by Siemens Medical Solutions USA, Inc.

510(k) K920587

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK920587 Date15 Jan 1993ClearedStatusActive

Official records

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  • Withdrawn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
DQK
Device class
Class II
Regulation
21 CFR Part 870.1425
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.

This device is a Computer, Diagnostic, Programmable system (product code DQK) designed for the measurement, display, and printout of bio-physiological events. It captures and processes hemodynamic and electrophysiological signals, including intracardiac pressure and ECG signals, enabling real-time monitoring and analysis of cardiac function. As a multi-channel system, it supports simultaneous acquisition and visualization of multiple physiological parameters, facilitating clinical assessment and diagnostic evaluation. The system is classified under Class II with Special Controls, reflecting its role in critical patient monitoring environments.

The Physiological Measurement and Display Systems are stationary, computer-based devices intended for use in clinical settings such as cardiac catheterization labs or intensive care units. They are not described as single-use or sterile in the provided data, though typical usage may require adherence to facility-specific infection control protocols. The device operates under FDA 510(k) clearance (K920587), granted in 1993, and is supplied as a reusable, programmable system. No MRI safety or sterility classifications are specified, and storage conditions are not detailed beyond standard environmental requirements for medical electronics.

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