The following data is part of a premarket notification filed by Nec Display Solutions, Ltd. with the FDA for Md302c4 29.8 Diagnostic Imaging Lcd Monitor.
Device ID | K133708 |
510k Number | K133708 |
Device Name: | MD302C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR |
Classification | System, Image Processing, Radiological |
Applicant | NEC DISPLAY SOLUTIONS, LTD. 1F, NO. 181, SEC. 2 WUNHUA 1ST ROAD, LINKOU TOWNSHIP New Taipei City, TW 24457 |
Contact | Tony Hsu |
Correspondent | Tony Hsu NEC DISPLAY SOLUTIONS, LTD. 1F, NO. 181, SEC. 2 WUNHUA 1ST ROAD, LINKOU TOWNSHIP New Taipei City, TW 24457 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-12-04 |
Decision Date | 2014-02-14 |
Summary: | summary |