Philips Hemodynamic Application R1.0— 510(k) K181311

Substantially Equivalent

Philips Medical Systems Nederlands B.V.

FDA 510(k) clearance K181311 for Philips Hemodynamic Application R1.0, Substantially Equivalent on 2018-09-07. Applicant: Philips Medical Systems Nederlands B.V..

Clearance details

Applicant: Philips Medical Systems Nederlands B.V.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2018-05-17
Decision date: 2018-09-07
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Best Noord-Brabant, 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.