BEUDAMED
    Product Code: NOH FDA class 1 21 CFR 886.1350

    Photokeratoscope, Battery Powered

    Ophthalmic

    The battery-powered photokeratoscope is an ophthalmic device used to examine the regularity and curvature of the corneal surface by projecting rings of light onto the cornea and analyzing the reflected image. It is classified as FDA Class 1 under regulation 886.1350 in the Ophthalmic specialty, and it is GMP exempt. Product code NOH does not require 510(k) clearance and is a battery-powered variant of the standard photokeratoscope.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
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    Unique Applicants
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    Years Active
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    Basic Information

    Product Code
    NOH
    Device Class
    FDA class 1
    Regulation Number
    886.1350
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    4

    Device Characteristics

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

    Definition

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