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

    SPSMEDICAL SPORVIEW STEAM BI TEST PACK

    K Number: K022706 · Decision Oct 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    202
    Applicant Total
    26
    Review Days
    72

    Basic Information

    Device Name
    SPSMEDICAL SPORVIEW STEAM BI TEST PACK
    K Number
    K022706
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SPS MEDICAL SUPPLY CORP.
    Date Received
    August 14, 2002
    Decision Date
    October 25, 2002
    Product Code
    FRC
    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
    FRC Indicator, Biological Sterilization Process

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    Other Clearances by SPS MEDICAL SUPPLY CORP.

    K Number Device Name
    K122024 SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR
    K130211 AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETS
    K111515 SPSMEDICAL SPORVIEW STEAM BI
    K102363 SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004
    K090650 SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS
    K081879 SPSMEDICAL SPORVIEW PA CULTURE SET
    K063799 STEAMPLUS STEAM INTEGRATOR
    K051173 SPSMEDICAL SPORVIEW PLUS STEAM BI TEST PACK
    K043135 SPSMEDICAL SPORVIEW PA CULTURE SET
    K041017 SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK
    Search all 26 clearances from SPS MEDICAL SUPPLY CORP. →