BEUDAMED
    Product Code: HKZ FDA class 1 21 CFR 886.1940

    Sterilizer, Tonometer

    Ophthalmic

    The Tonometer Sterilizer is a device used to disinfect or sterilize tonometer tips between patient examinations to prevent cross-contamination and transmission of ocular pathogens such as adenovirus or herpes simplex virus. It is classified as FDA Class 1, the lowest risk level, subject only to general controls without a premarket notification requirement. The product code is HKZ, regulated under 21 CFR 886.1940, within the Ophthalmic medical specialty. No special risk flags apply to this device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    HKZ
    Device Class
    FDA class 1
    Regulation Number
    886.1940
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.