The following data is part of a premarket notification filed by National Display Systems with the FDA for Axis-v Monochrome 5 Mp Display.
Device ID | K063066 |
510k Number | K063066 |
Device Name: | AXIS-V MONOCHROME 5 MP DISPLAY |
Classification | System, Image Processing, Radiological |
Applicant | NATIONAL DISPLAY SYSTEMS 16245 VINEYARD BLVD. Morgan Hill, CA 95037 |
Contact | Ron Hanson |
Correspondent | Denise Leung Klinker UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2006-10-06 |
Decision Date | 2007-08-03 |
Summary: | summary |