Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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041
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Date of Entry 04/04/2016
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FR Recognition Number
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10-73
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Standard | |
ANSI Z80.21-2010 (R2015) American National Standard for Ophthalmics - Instruments - General-Purpose Clinical Visual Acuity Charts |
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Scope/AbstractThis standard applies to displays of optotypes for all clinical visual acuity measurement systems thatuse recognition of high-contrast optotypes and that are designed for general use including optotypesprinted on opaque media, those intended for transillumination, electronically generated or projected displays. |
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§886.1150 |
Chart, Visual Acuity |
Class 1 |
HOX |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |