K230881 is an FDA 510(k) clearance for the Change Healthcare Cardiology Hemodynamics™. This device is classified as a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MWI).
Submitted by Change Healthcare Israel , Ltd. (Holon, IL). The FDA issued a Cleared decision on September 11, 2023, 165 days after receiving the submission on March 30, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K230881 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2023 |
| Decision Date | September 11, 2023 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |