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

    BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR

    K Number: K992767 · Decision Jan 10, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    264
    Applicant Total
    19
    Review Days
    146

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    Basic Information

    Device Name
    BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
    K Number
    K992767
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Albert Browne , Ltd.
    Date Received
    August 17, 1999
    Decision Date
    January 10, 2000
    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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    Other Clearances by Albert Browne , Ltd.

    K Number Device Name
    K063285 RELIANCE CI PROCESS INDICATOR
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    K060066 VERIFY 3-10 MIN FLASH INTEGRATOR
    K060103 ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS
    K051101 VERIFY FLASH INTEGRATOR
    K051056 VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR
    K032801 MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR
    K002741 BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK
    K002937 TST CONTROL INTEGRATOR FOR STEAM STERILIZERS
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