BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    EYEFEEL OPHTHALMIC WARMER

    K Number: K082087 · Decision Sep 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    377
    Registration Numbers
    377
    Same Product Code
    81
    Applicant Total
    2
    Review Days
    50

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    Basic Information

    Device Name
    EYEFEEL OPHTHALMIC WARMER
    K Number
    K082087
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5710
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bio-Lipid, Inc.
    Date Received
    July 23, 2008
    Decision Date
    September 11, 2008
    Product Code
    IMD
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IMD Pack, Hot Or Cold, Disposable

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    Other Clearances by Bio-Lipid, Inc.

    K Number Device Name
    K021843 EYEFEEL OPHTHALMIC WARMER