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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Predicted Values, Pulmonary Function
510(k) Number K150888
Device Name Shape-HF Cardiopulmonary Testing System
Applicant
SHAPE MEDICAL SYSTEMS, INC
5000 TOWNSHIP PARKWAY
MINNEAPOLIS,  MN  55110
Applicant Contact BERNARD HORWATH
Correspondent
HORWATH RESOURCE GROUP
4486 TIMBERLINE CT.
ST. PAUL,  MN  55127
Correspondent Contact BERNARD HORWATH
Regulation Number868.1890
Classification Product Code
BTY  
Date Received04/02/2015
Decision Date 01/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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