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

    TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)

    K Number: K042099 · Decision Dec 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    37
    Same Product Code
    57
    Applicant Total
    1
    Review Days
    128

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    Basic Information

    Device Name
    TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)
    K Number
    K042099
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1930
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Retinapharma Technologies, Inc.
    Date Received
    August 4, 2004
    Decision Date
    December 10, 2004
    Product Code
    HKX
    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
    HKX Tonometer, Ac-Powered

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