Comarch Healthcare SA is one of 10 FDA 510(k) medical device manufacturers from Poland in the dataset, ranked by real submission volume.
Comarch Healthcare SA - FDA 510(k) Cleared Devices
Recent clearances: Comarch e-Care Platform
1
Total
1
Cleared
0
Denied
Comarch Healthcare SA has 1 FDA 510(k) cleared medical devices. Based in Krakow, PL.
Historical record: 1 cleared submissions from 2018 to 2018. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Comarch Healthcare SA Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Mdi Consultants, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Comarch Healthcare SA
1 devices