Device Classification Name |
Transducer, Tremor
|
510(k) Number |
K140086 |
Device Name |
PERSONAL KINETIGRAPH (PKG) SYSTEM |
Applicant |
GKC MANUFACTURING PTY LTD. |
1801 ROCKVILLE PIKE |
SUITE 300 |
ROCKVILLE,
MD
20852
|
|
Applicant Contact |
MARIE SCHROEDER |
Correspondent |
GKC MANUFACTURING PTY LTD. |
1801 ROCKVILLE PIKE |
SUITE 300 |
ROCKVILLE,
MD
20852
|
|
Correspondent Contact |
MARIE SCHROEDER |
Regulation Number | 882.1950
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/14/2014 |
Decision Date | 08/22/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|