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

    LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM

    K Number: K952329 · Decision Jan 17, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    157
    Applicant Total
    7
    Review Days
    244

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    Basic Information

    Device Name
    LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM
    K Number
    K952329
    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
    May 18, 1995
    Decision Date
    January 17, 1996
    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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    K933764 LIFE-AIR 1000 PATIENT WARMING COVER
    K933593 LUMINOUS 150 FIBEROPTIC ILLUMINATOR
    K921866 LUMINOUS 250 FIBEROPTIC ILLUMINATOR
    K914382 LIFE-AIR 1000 HYPOTHERMIC TREATMENT SYSTEM
    K914383 LIFE-AIR 1000 PATIENT WARMING COVERS