Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K083332 |
Device Name |
MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK |
Applicant |
NEC DISPLAY SOLUTIONS, LTD. |
1F, NO. 181, SEC. 2 WUNHUA |
1ST ROAD, LINKOU TOWNSHIP |
TAIPE,
TW
244
|
|
Applicant Contact |
ANGUS HSU |
Correspondent |
NEC DISPLAY SOLUTIONS, LTD. |
1F, NO. 181, SEC. 2 WUNHUA |
1ST ROAD, LINKOU TOWNSHIP |
TAIPE,
TW
244
|
|
Correspondent Contact |
ANGUS HSU |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 11/12/2008 |
Decision Date | 01/09/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|