Recognition List Number: 026 Publication Date: 03/18/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-191: ANSI S3.22:2009, American National Standard Specification of Hearing Aid Characteristics. (Dental/ENT)
Date of Standard: 2009. |
| Address of Standards Organization: |
| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
| |
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| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED) |
|
| (2) | OFFICE OF COMPLIANCE (OC) | | |
|
|
| Devices Affected: |
| Air-Conduction Hearing Aid Calibrator and Analysis System |
|
| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE, Design Control Input, 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 |
| §874.3300 |
Hearing Aid, Air Conduction |
Class 1 |
ESD |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §874.3310 |
Calibrator, Hearing Aid / Earphone And Analysis Systems |
Class 2 |
ETW |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §874.3320 |
Hearing Aid, Group And Auditory Trainer |
Class 2 |
EPF |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| 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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