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

    SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100

    K Number: K073712 · Decision Jun 6, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    157
    Applicant Total
    6
    Review Days
    158

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    Basic Information

    Device Name
    SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100
    K Number
    K073712
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Adroit Medical Systems, Inc.
    Date Received
    December 31, 2007
    Decision Date
    June 6, 2008
    Product Code
    DWJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DWJ System, Thermal Regulating

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