Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-123: ANSI S3.6-2004, Specification for Audiometers. (Dental/ENT)
Date of Standard: 2004. |
| 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) | | DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED) |
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| Devices Affected: |
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| Processes Affected: |
| 510(K), PMA, PDP, IDE, HDE, Design Control Input, Quallity System Regulation |
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| Type of Standard: |
| National, Vertical |
| 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 |
| §874.1050 |
Audiometer |
Class 2 |
EWO |
| |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Shu-Chen Peng |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66 Room 2446 |
| Silver Spring MD 20993 |
| 301/796-6481 |
| Email: shu-chen.peng@fda.hhs.gov |
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