K230881
- 510(k) number
- K230881
- Device name
- Change Healthcare Cardiology Hemodynamics
- Applicant
- Change Healthcare Israel , Ltd. IL
- Product code
- MWI — Monitor, Physiological, Patient (Without Arrhythmia
- Decision date
- 2023-09-11
- Date received
- 2023-03-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K230881.pdf
Official FDA record: K230881
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.