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

    VERIFUSE AMBULATORY PUMP

    K Number: K934551 · Decision Mar 17, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    30
    Applicant Total
    12
    Review Days
    176

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    Basic Information

    Device Name
    VERIFUSE AMBULATORY PUMP
    K Number
    K934551
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Block Medical, Inc.
    Date Received
    September 22, 1993
    Decision Date
    March 17, 1994
    Product Code
    MEA
    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
    MEA Pump, Infusion, Pca

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    Other Clearances by Block Medical, Inc.

    K Number Device Name
    K944692 C-SERIES HOMEPUMP
    K940117 MID-500
    K935236 FLOW CONTROLLING EXTENSION SET
    K932740 HOMEPUMP NSF
    K904663 AUTO SASH (TM)
    K914924 CHEMO PRIMING PIN(TM)
    K914854 THUMPER
    K914855 MULTIPLE DOSE CONTROLLER
    K910695 AUTO SASH (TM)
    K902891 VERIFUSE AMBULATORY PUMP
    Search all 12 clearances from Block Medical, Inc. →