BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    Icare HOME tonometer

    K Number: K163343 · Decision Mar 21, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    55
    Applicant Total
    7
    Review Days
    112

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    Basic Information

    Device Name
    Icare HOME tonometer
    K Number
    K163343
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1930
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Icare Finland OY
    Date Received
    November 29, 2016
    Decision Date
    March 21, 2017
    Product Code
    HKY
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HKY Tonometer, Manual

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    Other Clearances by Icare Finland OY

    K Number Device Name
    K241447 iCare ST500 (TA04)
    K220852 iCare IC200
    K211355 iCare HOME2
    K200966 Icare HOME Tonometer
    K190316 Icare ic200
    K153694 Icare ic100