Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 10-74: ISO 10940 Second edition 2009-08-01, Ophthalmic instruments - Fundus Cameras. (Ophthalmic)
Date of Standard: 2009. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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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: |
| 510(k), PMA, IDE, PDP, HDE, Design Controls |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
| Complete standard and any annexes, EXCEPT Clause 4.4 (a) (1) Group 1 fundus camera; the lower limit should be set at 915 nm. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §886.1120 |
Camera, Ophthalmic, Ac-Powered |
Class 2 |
HKI |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Dexiu Shi |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2246 |
| Silver Spring MD 20993 |
| 301/796-6860 |
| Email: dexiu.shi@fda.hhs.gov |
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