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

    MORELL INJECTOR

    K Number: K951870 · Decision Jan 22, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    154
    Applicant Total
    5
    Review Days
    276

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    Basic Information

    Device Name
    MORELL INJECTOR
    K Number
    K951870
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5140
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Incutech, Inc.
    Date Received
    April 21, 1995
    Decision Date
    January 22, 1996
    Product Code
    CAZ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CAZ Anesthesia Conduction Kit

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    Other Clearances by Incutech, Inc.

    K Number Device Name
    K960619 MORE-L INJECTOR KIT PLUS
    K942394 SAFE VENT SYSTEM
    K941731 EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET
    K940258 SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY)