Device Classification Name |
Electromyograph, Diagnostic
|
510(k) Number |
K864408 |
Device Name |
EMG-1, MOTOR NERVE MONITOR |
Applicant |
ALGOTEK, INC. |
2464 EMBARCADERO WAY |
PALO ALTO,
CA
94303
|
|
Applicant Contact |
MAURIZIO LIVERANI |
Correspondent |
ALGOTEK, INC. |
2464 EMBARCADERO WAY |
PALO ALTO,
CA
94303
|
|
Correspondent Contact |
MAURIZIO LIVERANI |
Regulation Number | 890.1375
|
Classification Product Code |
|
Date Received | 11/10/1986 |
Decision Date | 01/30/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|