Device Classification Name |
Electromyograph, Diagnostic
|
510(k) Number |
K944787 |
Device Name |
INTEGRATED MOVEMENT ANALYZER |
Applicant |
MARYROSE |
5530 CORBIN AVE. |
SUITE #315 |
TARZANA,
CA
91356
|
|
Applicant Contact |
MARYROSE CUSIMANO |
Correspondent |
MARYROSE |
5530 CORBIN AVE. |
SUITE #315 |
TARZANA,
CA
91356
|
|
Correspondent Contact |
MARYROSE CUSIMANO |
Regulation Number | 890.1375
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/28/1994 |
Decision Date | 07/07/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|