Medical Device Manufacturer · US , Minneapolis , MN

Shape Medical Systems, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2009

Recent clearances: Shape-HF Cardiopulmonary Testing System, SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM

View 2 510(k) Devices ↓
2
Total
2
Cleared
0
Denied

FDA 510(k) Regulatory Record - Shape Medical Systems, Inc. Anesthesiology ✕

2 devices
1-2 of 2
Cleared Jan 21, 2016
Shape-HF Cardiopulmonary Testing System
K150888 · BTY
Anesthesiology · 294d
Cleared Mar 31, 2009
SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
K090722 · BTY
Anesthesiology · 12d
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