Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K162559 |
Device Name |
Move Forward 3D Motion Simulation Service |
Applicant |
BIOMET INC. |
56 EAST BELL DRIVE |
WARSAW,
IN
46581
|
|
Applicant Contact |
PAUL HARDY |
Correspondent |
BIOMET INC. |
56 EAST BELL DRIVE |
WARSAW,
IN
46581
|
|
Correspondent Contact |
PAUL HARDY |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 09/14/2016 |
Decision Date | 03/31/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|