Device Classification Name |
electromyograph, diagnostic
|
510(k) Number |
K002104 |
Device Name |
COMBINED PHYSIOLOGICAL MONITORING SYSTEM |
Applicant |
MARYROSE CUSIMANO, PH.D. & SCOTT ZEFF |
7481 W. OAKLAND PARK BLVD. |
# 305 |
FT. LAUDERDALE,
FL
33319
|
|
Applicant Contact |
MARYROSE CUSIMANO |
Correspondent |
MARYROSE CUSIMANO, PH.D. & SCOTT ZEFF |
7481 W. OAKLAND PARK BLVD. |
# 305 |
FT. LAUDERDALE,
FL
33319
|
|
Correspondent Contact |
MARYROSE CUSIMANO |
Regulation Number | 890.1375
|
Classification Product Code |
|
Date Received | 07/12/2000 |
Decision Date | 10/10/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|