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

    HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS

    K Number: K943654 · Decision Aug 2, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    46
    Applicant Total
    8
    Review Days
    370

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    Basic Information

    Device Name
    HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS
    K Number
    K943654
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mdt Biologic Co.
    Date Received
    July 28, 1994
    Decision Date
    August 2, 1995
    Product Code
    MLR
    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
    MLR Sterilizer, Chemical

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