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

    PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM

    K Number: K864087 · Decision Nov 7, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    62
    Applicant Total
    6
    Review Days
    17

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    Basic Information

    Device Name
    PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM
    K Number
    K864087
    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
    October 21, 1986
    Decision Date
    November 7, 1986
    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.

    K Number Device Name
    K921178 PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS
    K903939 PANDA HELIUM GAS ANALYZER
    K893845 PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM
    K883008 PULMONARY FORCED FLOW SYSTEM (PUFFS)
    K881122 UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG.