BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Shape-HF Cardiopulmonary Testing System

    K Number: K150888 · Decision Jan 21, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    62
    Applicant Total
    2
    Review Days
    294

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    Basic Information

    Device Name
    Shape-HF Cardiopulmonary Testing System
    K Number
    K150888
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1890
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shape Medical Systems, Inc.
    Date Received
    April 2, 2015
    Decision Date
    January 21, 2016
    Product Code
    BTY
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTY Calculator, Predicted Values, Pulmonary Function

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    Other Clearances by Shape Medical Systems, Inc.

    K Number Device Name
    K090722 SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM