Device Classification Name |
Device, Muscle Monitoring
|
510(k) Number |
K082927 |
Device Name |
BIOEMG III |
Applicant |
BIO-RESEARCH ASSOCIATES, INC. |
9275 NORTH 49TH STREET |
SUITE 150 |
BROWN DEER,
WI
53223
|
|
Applicant Contact |
JOHN RADKE |
Correspondent |
BIO-RESEARCH ASSOCIATES, INC. |
9275 NORTH 49TH STREET |
SUITE 150 |
BROWN DEER,
WI
53223
|
|
Correspondent Contact |
JOHN RADKE |
Regulation Number | 890.1375
|
Classification Product Code |
|
Date Received | 10/01/2008 |
Decision Date | 02/06/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|