QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP— 510(k) K170032

Substantially Equivalent

Fysicon BV

FDA 510(k) clearance K170032 for QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP, Substantially Equivalent on 2017-09-08. Applicant: Fysicon BV.

Clearance details

Applicant: Fysicon BV
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2017-01-04
Decision date: 2017-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oss, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.