Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-185: ANSI S3.45-2009 (Revision of ANSI S3.45-1999), American National Standard Procedures for Testing Basic Vestibular Function. (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 |
| |
|
| 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: |
| Nystagmograph, Platform, Force-measuring |
|
| Processes Affected: |
| 510(k), IDE, PMA, PDP, HDE, Quality System Regulation |
|
| Type of Standard: |
| Vertical, National |
| Extent of Recognition: |
| Complete standard and any annexes. |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §882.1460 |
Nystagmograph |
Class 2 |
GWN |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §890.1575 |
Platform, Force-Measuring |
Class 1 |
KHX |
| |
|
| 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 |
|
|
