BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ACOUSTIC RECORDER

    K Number: K943726 · Decision Nov 30, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    120

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    Basic Information

    Device Name
    ACOUSTIC RECORDER
    K Number
    K943726
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.2390
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Technology Applications Assoc., Inc.
    Date Received
    August 2, 1994
    Decision Date
    November 30, 1994
    Product Code
    DQC
    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
    DQC Phonocardiograph

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