The following data is part of a premarket notification filed by Western Systems Research, Inc. with the FDA for Vestibular Autorotation Test.
Device ID | K871466 |
510k Number | K871466 |
Device Name: | VESTIBULAR AUTOROTATION TEST |
Classification | Nystagmograph |
Applicant | WESTERN SYSTEMS RESEARCH, INC. 2265 WESTWOOD BLVD., STE 545 Los Angeles, CA 90064 |
Contact | Linda L Davis |
Correspondent | Linda L Davis WESTERN SYSTEMS RESEARCH, INC. 2265 WESTWOOD BLVD., STE 545 Los Angeles, CA 90064 |
Product Code | GWN |
CFR Regulation Number | 882.1460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-14 |
Decision Date | 1987-07-24 |