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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    VEGA ULTRASONIC NEBULIZER

    K Number: K002831 · Decision May 23, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    6
    Review Days
    254

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    Basic Information

    Device Name
    VEGA ULTRASONIC NEBULIZER
    K Number
    K002831
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vega Technologies, Inc.
    Date Received
    September 11, 2000
    Decision Date
    May 23, 2001
    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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    Other Clearances by Vega Technologies, Inc.

    K Number Device Name
    K102625 VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03
    K102934 INFRARED EAR THERMOMETER, MODEL IR-04MT
    K102626 VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01
    K041516 DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9
    K031413 VIGORMIST COMPRESSOR NEBULIZER