The following data is part of a premarket notification filed by Nec Display Solutions, Ltd. with the FDA for Md211c2 21.3 Diagnostic Imaging Lcd Monitor.
Device ID | K130772 |
510k Number | K130772 |
Device Name: | MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR |
Classification | System, Image Processing, Radiological |
Applicant | NEC DISPLAY SOLUTIONS, LTD. 1F, # 181, S. 2, WUNHUA 1ST RD LINKOU TOWNSHIP Taipei, TW 24447 |
Contact | Angus Hsu |
Correspondent | Jeffrey D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2013-03-20 |
Decision Date | 2013-04-18 |
Summary: | summary |