Recognition List Number: 019 Publication Date: 12/19/2007
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 10-37: ISO 10942 Second edition 2006-06-01, Ophthalmic instruments -- Direct ophthalmoscopes. (Ophthalmic)
Date of Standard: 2006. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
|
SWITZERLAND
|
|
| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED) |
|
|
| Devices Affected: |
| Direct Ophthalmoscopes, AC and DC Powered |
|
| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE, Design Control Input |
|
| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
| Sections 5.5, 6.2, 7, 8 and Annexes A, B, & C |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §886.1570 |
Ophthalmoscope, Battery-Powered |
Class 2 |
HLJ |
| §886.1570 |
Ophthalmoscope,Laser,Scanning |
Class 2 |
MYC |
| |
|
| Relevant Guidance: |
| Guidance for Industry Ophthalmoscope Guidance - (Direct and Indirect), Issued July 8, 1998 |
|
| FDA Technical Contact: |
| Sharon A. Miller |
| FDA/CDRH/OCER |
| 10903 New Hampshire Avenue Building 66, Room 4661 |
| Silver Spring MD 20993 |
| 301/796-2471 |
| Email: sharona.miller@fda.hhs.gov |
|
|
|
| * In the United States, copies of this standard can be obtained from: |
| American National Standards Institute (ANSI)* |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
|
|
