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

    PrevisEA Device

    K Number: K211068 · Decision Aug 4, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    153
    Applicant Total
    2
    Review Days
    114

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    Basic Information

    Device Name
    PrevisEA Device
    K Number
    K211068
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Entac Medical, Inc.
    Date Received
    April 12, 2021
    Decision Date
    August 4, 2021
    Product Code
    DQD
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DQD Stethoscope, Electronic

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    Other Clearances by Entac Medical, Inc.

    K Number Device Name
    K230769 PrevisEA Device