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

    MEDI - PUMP

    K Number: K950290 · Decision Aug 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    9
    Review Days
    211

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    Basic Information

    Device Name
    MEDI - PUMP
    K Number
    K950290
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Thomas Industries
    Date Received
    January 25, 1995
    Decision Date
    August 24, 1995
    Product Code
    CAF
    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
    CAF Nebulizer (Direct Patient Interface)

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    Other Clearances by Thomas Industries

    K Number Device Name
    K041199 MEDI-PUMP ASPIRATOR, MODEL 1615
    K965059 CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243)
    K952806 MEDI PUMP ASPIRATOR MODELS 1130 AND 1135
    K951729 MEDI - PUMP
    K950867 MEDI - PUMP
    K944399 MEDI-PUMP
    K925010 NEBULIZER PUMP, POWERED, MODEL 1110
    K925011 NEBULIZER PUMP, POWERED MODEL 1180