Shape-HF Cardiopulmonary Testing System— 510(k) K150888
Substantially EquivalentShape Medical Systems, Inc.
FDA 510(k) clearance K150888 for Shape-HF Cardiopulmonary Testing System, Substantially Equivalent on 2016-01-21. Applicant: Shape Medical Systems, Inc..
Clearance details
- Applicant
- Shape Medical Systems, Inc.
- Product code
- Code BTY
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.