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

    MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) )

    K Number: K942747 · Decision Jul 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    20
    Applicant Total
    2
    Review Days
    41

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    Basic Information

    Device Name
    MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) )
    K Number
    K942747
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Engineered Orthopedic Technologies, Inc.
    Date Received
    June 10, 1994
    Decision Date
    July 21, 1994
    Product Code
    KDP
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KDP Regulator, Vacuum

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    Other Clearances by Engineered Orthopedic Technologies, Inc.

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