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

    GERATHERM SOS-RESCUE BAG

    K Number: K051336 · Decision Jun 29, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    157
    Applicant Total
    1
    Review Days
    402

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    GERATHERM SOS-RESCUE BAG
    K Number
    K051336
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    R.G. Enterprises, Inc.
    Date Received
    May 23, 2005
    Decision Date
    June 29, 2006
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DWJ), ordered by most recent decision date.

    Hot Pink Pad Warming System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Warming System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arctic Sun Temperature Management System (Model 5000)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Celsi Warmer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arctic Sun Stat Temperature Management System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HotDog Warming Mattress + Return Electrode

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all