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

    MODIFICATION TO TRANSPORT INCUBATOR 185

    K Number: K031096 · Decision Jun 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    24
    Applicant Total
    5
    Review Days
    78

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    Basic Information

    Device Name
    MODIFICATION TO TRANSPORT INCUBATOR 185
    K Number
    K031096
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5410
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    International Biomedics, Inc.
    Date Received
    April 7, 2003
    Decision Date
    June 24, 2003
    Product Code
    FPL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FPL Incubator, Neonatal Transport

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