Device Classification Name |
Device, Muscle Monitoring
|
510(k) Number |
K003176 |
Device Name |
BIOEMG II AND BIOJVA |
Applicant |
BIO-RESEARCH ASSOCIATES, INC. |
4113 NORTH PORT WASHINGTON RD. |
MILWAUKEE,
WI
53212
|
|
Applicant Contact |
JOHN C RADKE |
Correspondent |
BIO-RESEARCH ASSOCIATES, INC. |
4113 NORTH PORT WASHINGTON RD. |
MILWAUKEE,
WI
53212
|
|
Correspondent Contact |
JOHN C RADKE |
Regulation Number | 890.1375
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/11/2000 |
Decision Date | 01/04/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|