Philips Hemodynamic Application R1.0— 510(k) K181311
Substantially EquivalentPhilips 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.. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems Nederlands B.V.
- Product code
- Code MWI
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Best Noord-Brabant, NL
Recent devices under product code MWI
view allMore clearances from Philips Medical Systems Nederlands B.V.
view allAdverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K181311
K-number listed on FDA's recall record- Z-1926-2024 — Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
- Z-1041-2022 — Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient hemodynamic data in the Philips Interventional Hemodynamic System.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181311.
Data sourced from openFDA. This site is unofficial and independent of the FDA.