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

    ETHYLENE OXIDE GAS STERILIZA SYS II

    K Number: K833457 · Decision Dec 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    25
    Applicant Total
    1
    Review Days
    85

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ETHYLENE OXIDE GAS STERILIZA SYS II
    K Number
    K833457
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Ben Venue Laboratories, Inc.
    Date Received
    October 5, 1983
    Decision Date
    December 29, 1983
    Product Code
    FLF
    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
    FLF Sterilizer, Ethylene-Oxide Gas

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FLF), ordered by most recent decision date.

    EOGas 4 Ethylene Oxide Gas Sterilizer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Anprolene AN75 Ethylene Oxide Gas Sterilizer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EOGas 4 Ethylene Oxide Gas Sterilizer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    3M STERI-VAC STERILIZER/AERATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TSO3 OZONE STERILIZER, MODEL 125L

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TSO3 OZONE STERILIZER, MODEL 125L

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all