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Shape-HF Cardiopulmonary Testing System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150888
510(k) Type
Traditional
Applicant
SHAPE MEDICAL SYSTEMS, INC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/21/2016
Days to Decision
294 days
Submission Type
Summary

Shape-HF Cardiopulmonary Testing System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150888
510(k) Type
Traditional
Applicant
SHAPE MEDICAL SYSTEMS, INC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/21/2016
Days to Decision
294 days
Submission Type
Summary