The following data is part of a premarket notification filed by Nec Display Solutions, Ltd. with the FDA for Md301c4 29.8 Diagnostic Imaging Lcd Monitor, L309ty.
Device ID | K111237 |
510k Number | K111237 |
Device Name: | MD301C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR, L309TY |
Classification | System, Image Processing, Radiological |
Applicant | NEC DISPLAY SOLUTIONS, LTD. 1F, NO. 181, SEC. 2 WUNHUA 1ST ROAD, LINKOU TOWNSHIP New Taipei City, TW 2447 |
Contact | Angus Hsu |
Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2011-05-02 |
Decision Date | 2011-06-15 |
Summary: | summary |