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

    VENTI-GENTLE-HALER(TM)

    K Number: K933915 · Decision Oct 28, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    28
    Review Days
    79

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    Basic Information

    Device Name
    VENTI-GENTLE-HALER(TM)
    K Number
    K933915
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vortran Medical Technology 1, Inc.
    Date Received
    August 10, 1993
    Decision Date
    October 28, 1993
    Product Code
    CAF
    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
    CAF Nebulizer (Direct Patient Interface)

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    K073261 VAR MONITOR
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