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

    STONY BROOK MODEL EECP-MC1

    K Number: K882401 · Decision Mar 3, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    33
    Applicant Total
    1
    Review Days
    266

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    Basic Information

    Device Name
    STONY BROOK MODEL EECP-MC1
    K Number
    K882401
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5225
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Stony Brook Trading and Development Corp.
    Date Received
    June 10, 1988
    Decision Date
    March 3, 1989
    Product Code
    DRN
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DRN Device, Counter-Pulsating, External

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