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

    MEDI + BIO SAFE STEAM STERILIZ. INDICAT

    K Number: K821997 · Decision Aug 16, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    262
    Applicant Total
    2
    Review Days
    40

    Basic Information

    Device Name
    MEDI + BIO SAFE STEAM STERILIZ. INDICAT
    K Number
    K821997
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    ARVEY CORP.
    Date Received
    July 7, 1982
    Decision Date
    August 16, 1982
    Product Code
    JOJ
    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
    JOJ Indicator, Physical/Chemical Sterilization Process

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