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

    INCUWARMER

    K Number: K971366 · Decision Jan 5, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    91
    Applicant Total
    33
    Review Days
    266

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    Basic Information

    Device Name
    INCUWARMER
    K Number
    K971366
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5130
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hill-Rom, Inc.
    Date Received
    April 14, 1997
    Decision Date
    January 5, 1998
    Product Code
    FMT
    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
    FMT Warmer, Infant Radiant

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    Other Clearances by Hill-Rom, Inc.

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