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

    LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM

    K Number: K914382 · Decision Apr 21, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    154
    Applicant Total
    7
    Review Days
    203

    Basic Information

    Device Name
    LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM
    K Number
    K914382
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    PROGRESSIVE DYNAMICS, INC.
    Date Received
    October 1, 1991
    Decision Date
    April 21, 1992
    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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    Other Clearances by PROGRESSIVE DYNAMICS, INC.

    K Number Device Name
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    K944688 LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR
    K933764 LIFE-AIR 1000 PATIENT WARMING COVER
    K933593 LUMINOUS 150 FIBEROPTIC ILLUMINATOR
    K921866 LUMINOUS 250 FIBEROPTIC ILLUMINATOR
    K914383 LIFE-AIR 1000 PATIENT WARMING COVERS