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

    TEARLAB OSMOLARITY SYSTEM

    K Number: K083184 · Decision May 14, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    198

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    Basic Information

    Device Name
    TEARLAB OSMOLARITY SYSTEM
    K Number
    K083184
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1540
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ocusense, Inc.
    Date Received
    October 28, 2008
    Decision Date
    May 14, 2009
    Product Code
    OND
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OND Osmolality Of Tears