Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 10-73: ANSI Z80.21-2010, American National Standard for Ophthalmics - Instruments - General - Purpose Clinical Visual Acuity Charts. (Ophthalmic)
Date of Standard: 2010. |
| Address of Standards Organization: |
| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
| |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) |
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| Devices Affected: |
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| Processes Affected: |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
| Complete standard and any annexes. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §886.1150 |
Chart, Visual Acuity |
Class 1 |
HOX |
| |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Bruce Drum, Ph.D. |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2418 |
| Silver Spring MD 20993 |
| 301/796-6466 |
| Email: bruce.drum@fda.hhs.gov |
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