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

    MODEL TI500 ISOLETTE INFANT INCUBATOR

    K Number: K941106 · Decision Jun 10, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    24
    Applicant Total
    33
    Review Days
    95

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    Basic Information

    Device Name
    MODEL TI500 ISOLETTE INFANT INCUBATOR
    K Number
    K941106
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5410
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Air-Shields, Inc.
    Date Received
    March 7, 1994
    Decision Date
    June 10, 1994
    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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