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

    SAFE VENT SYSTEM

    K Number: K942394 · Decision Jan 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    5
    Review Days
    253

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    Basic Information

    Device Name
    SAFE VENT SYSTEM
    K Number
    K942394
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Incutech, Inc.
    Date Received
    May 19, 1994
    Decision Date
    January 27, 1995
    Product Code
    FMF
    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
    FMF Syringe, Piston

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    Other Clearances by Incutech, Inc.

    K Number Device Name
    K960619 MORE-L INJECTOR KIT PLUS
    K951870 MORELL INJECTOR
    K941731 EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET
    K940258 SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY)