Device Classification Name |
Electromyograph, Diagnostic
|
510(k) Number |
K123902 |
Device Name |
PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) |
Applicant |
OKTX LLC |
7225 S 85TH E AVE. |
SUITE 300 |
TULSA,
OK
74137
|
|
Applicant Contact |
MARY ROSE C REASTON |
Correspondent |
OKTX LLC |
7225 S 85TH E AVE. |
SUITE 300 |
TULSA,
OK
74137
|
|
Correspondent Contact |
MARY ROSE C REASTON |
Regulation Number | 890.1375
|
Classification Product Code |
|
Date Received | 12/18/2012 |
Decision Date | 09/13/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|