Change Healthcare Cardiology Hemodynamics— 510(k) K230881
Substantially EquivalentChange Healthcare Israel , Ltd.
FDA 510(k) clearance K230881 for Change Healthcare Cardiology Hemodynamics, Substantially Equivalent on 2023-09-11. Applicant: Change Healthcare Israel , Ltd.. Device class: 2.
Clearance details
- Applicant
- Change Healthcare Israel , Ltd.
- 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
- Traditional
- Location
- Holon, IL
Recent devices under product code MWI
view allMore clearances from Change Healthcare Israel , Ltd.
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 K230881
K-number listed on FDA's recall record- Z-2072-2025 — Change Healthcare Cardiology Hemodynamics Software
- Z-0959-2025 — Change Healthcare Cardiology Hemodynamics software
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K230881.
Data sourced from openFDA. This site is unofficial and independent of the FDA.