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

    VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03

    K Number: K102625 · Decision Jun 10, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    6
    Review Days
    270

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    Basic Information

    Device Name
    VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03
    K Number
    K102625
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vega Technologies, Inc.
    Date Received
    September 13, 2010
    Decision Date
    June 10, 2011
    Product Code
    BZD
    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
    BZD Ventilator, Non-Continuous (Respirator)

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