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QMAPP Amplifier - QMAPP Amplifier

by Fysicon BV

510(k) K170032

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170032↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK170032 Date8 Sep 2017ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
MWI
Models / Variants
QMAPP Amplifier
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

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

The QMAPP Amplifier is a Hemodynamic Monitoring Amplifier designed to process and amplify physiological signals for accurate hemodynamic parameter measurement. It serves as a critical component in systems for assessing cardiac output, blood pressure, and other circulatory dynamics, enabling precise clinical monitoring.

This device is supplied as part of the QMAPP Hemodynamic Monitoring System and is intended for use in clinical settings such as intensive care units, operating rooms, and cardiac care units. It is regulated under FDA 510K and MDR, with a clearance type classified as Traditional. The system is not specified as single-use or reusable, and no MRI safety information is provided. Storage and handling instructions are not detailed in the specifications.

Other devices from Fysicon BV

Questions

AI-generated answers, 18 Sep 2026

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

  • What clinical settings is the QMAPP Amplifier primarily designed for use in, and what key functions does it perform there?

    The QMAPP Amplifier is designed for critical monitoring environments like intensive care units, operating rooms, and cardiac care units. It processes and amplifies physiological signals to enable accurate measurement of hemodynamic parameters such as cardiac output and blood pressure, supporting real-time assessment of circulatory dynamics for patient care.

  • Is the QMAPP Amplifier intended for single-use or can it be reused in clinical settings?

    The provided specifications do not explicitly state whether the QMAPP Amplifier is single-use or reusable. This detail would need to be confirmed through manufacturer guidelines or additional documentation, as it is not mentioned in the regulatory data.

  • How is the QMAPP Amplifier regulated, and what type of clearance does it hold?

    The QMAPP Amplifier is regulated under both FDA 510K and MDR (Medical Device Regulation) frameworks. Its clearance type is classified as *Traditional*, meaning it was determined to be substantially equivalent to a legally marketed predicate device through a traditional 510(k) review process.

  • What types of systems does the QMAPP Amplifier integrate with, and what are its core components?

    The QMAPP Amplifier is a core component of the QMAPP Hemodynamic Monitoring System, which includes variants like the QMAPP PCM, QMAPP GO, and QMAPP EP. It works alongside these modules to amplify and process signals for precise hemodynamic monitoring, enabling comprehensive assessment of cardiac and circulatory function in clinical settings.