Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-164: ANSI S3.7-1997 (Reaffirmed 2003) (Reaffirmed 2008), Method for Coupler Calibration of Earphones. (Dental/ENT)
Date of Standard: 2008. |
| Address of Standards Organization: |
| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
| |
|
| 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: |
| Diagnostic Test Equipment, Diagnostic Test Equipmenet Calibrators |
|
| Processes Affected: |
| 510(k), IDE, PMA, PDP, HDE, Quality System Regulation |
|
| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
| Complete standard and any annexes. |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §874.1050 |
Audiometer |
Class 2 |
EWO |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §874.1080 |
Set, Audiometer Calibration |
Class 1 |
EWA |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Vansant Dasika |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2443 |
| Silver Spring MD 20993 |
| 301/796-5365 |
| Email: vasant.dasika@fda.hhs.gov |
|
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