Device Classification Name |
electromyograph, diagnostic
|
510(k) Number |
K922488 |
Device Name |
PHASIS ELECTROMYOGRAPH |
Applicant |
BIOSOUND, INC. |
6110 BOLLINGER RD. |
SAN JOSE,
CA
95129
|
|
Applicant Contact |
WILLIAM E MCKAY |
Correspondent |
BIOSOUND, INC. |
6110 BOLLINGER RD. |
SAN JOSE,
CA
95129
|
|
Correspondent Contact |
WILLIAM E MCKAY |
Regulation Number | 890.1375
|
Classification Product Code |
|
Date Received | 05/27/1992 |
Decision Date | 03/02/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|