Device Classification Name |
Device, Biofeedback
|
510(k) Number |
K925197 |
Device Name |
PSI 220 DUAL EMG |
Applicant |
FASSTECH |
155 MIDDLESEX TURNPIKE |
BURLINGTON,
MA
01803
|
|
Applicant Contact |
RICHARD BRODY |
Correspondent |
FASSTECH |
155 MIDDLESEX TURNPIKE |
BURLINGTON,
MA
01803
|
|
Correspondent Contact |
RICHARD BRODY |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 10/15/1992 |
Decision Date | 02/02/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|