Shape Medical Systems, Inc. is one of 18354 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Shape Medical Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Shape-HF Cardiopulmonary Testing System, SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
2
Total
2
Cleared
0
Denied
Shape Medical Systems, Inc. has 2 FDA 510(k) cleared medical devices. Based in Minneapolis, US.
Historical record: 2 cleared submissions from 2009 to 2016. Primary specialty: Anesthesiology.
Browse the FDA 510(k) cleared devices submitted by Shape Medical Systems, Inc. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Intertek Testing Services and Horwath Resource Group.
FDA 510(k) Regulatory Record - Shape Medical Systems, Inc.
2 devices