Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-90: ANSI / ASA ASA S3.39:1987 (Reaffirmed by ANSI May 18, 2007), Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance). (Dental/ENT)
Date of Standard: 1987. |
| Addresses of Standards Organizations: |
| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
| |
| Acoustical Society of America (ASA) |
| 500 Sunnyside Boulevard |
| Woodbury, NY 11797-2999 |
| |
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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) | | | | |
|
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| Devices Affected: |
| Auditory Impedance Tester |
|
| Processes Affected: |
| 510(K), PMA, IDE, 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 |
| §874.1090 |
Tester, Auditory Impedance |
Class 2 |
ETY |
| |
|
| 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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