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

    AIR PLETHYSMOGRAPH MODEL APG-1000

    K Number: K881291 · Decision Oct 14, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    113
    Applicant Total
    6
    Review Days
    200

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    Basic Information

    Device Name
    AIR PLETHYSMOGRAPH MODEL APG-1000
    K Number
    K881291
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2770
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Aci Medical, Inc.
    Date Received
    March 28, 1988
    Decision Date
    October 14, 1988
    Product Code
    DSB
    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
    DSB Plethysmograph, Impedance

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