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

    COBE PATIENT MONITORING PRODUCTS

    K Number: K921343 · Decision Jan 5, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    147
    Applicant Total
    43
    Review Days
    292

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    Basic Information

    Device Name
    COBE PATIENT MONITORING PRODUCTS
    K Number
    K921343
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2850
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cobe Cardiovascular, Inc.
    Date Received
    March 19, 1992
    Decision Date
    January 5, 1993
    Product Code
    DRS
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRS Transducer, Blood-Pressure, Extravascular

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    K033641 SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
    K030462 COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
    K021830 SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
    K011835 COBE REVOLUTION
    K013480 COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
    K012763 SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
    K001509 STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE
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