Device Classification Name |
Electromyograph, Diagnostic
|
510(k) Number |
K123399 |
Device Name |
MYOVISION 3.0 WIREFREE SYSTEM |
Applicant |
PRECISION BIOMETRICS, INC. |
2303 W Commodore Way Ste 301 |
Seattle,
WA
98199
|
|
Applicant Contact |
ERIC CHEN |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 890.1375
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/05/2012 |
Decision Date | 08/01/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|