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

    UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG.

    K Number: K881122 · Decision Jun 10, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    62
    Applicant Total
    6
    Review Days
    86

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    Basic Information

    Device Name
    UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG.
    K Number
    K881122
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1890
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Medical Associated Services, Inc.
    Date Received
    March 16, 1988
    Decision Date
    June 10, 1988
    Product Code
    BTY
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BTY Calculator, Predicted Values, Pulmonary Function

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    Other Clearances by Medical Associated Services, Inc.

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    K864087 PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM