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

    DSP100 AMPLIFIER

    K Number: K860814 · Decision Dec 5, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    17
    Applicant Total
    5
    Review Days
    276

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    Basic Information

    Device Name
    DSP100 AMPLIFIER
    K Number
    K860814
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.2390
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Intl. Acoustics, Inc.
    Date Received
    March 4, 1986
    Decision Date
    December 5, 1986
    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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    Other Clearances by Intl. Acoustics, Inc.

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    K844997 IAI PROGRAM-COMPUTER PROGRAM