The following data is part of a premarket notification filed by National Display Systems with the FDA for Axis I (1mp), Ii (2mp), Iii (3mp), And V (5mp) Monochrome Displays.
Device ID | K042353 |
510k Number | K042353 |
Device Name: | AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS |
Classification | System, Image Processing, Radiological |
Applicant | NATIONAL DISPLAY SYSTEMS 16245 VINEYARD BLVD. Morgan Hill, CA 95037 |
Contact | Ron Hansen |
Correspondent | Ron Hansen NATIONAL DISPLAY SYSTEMS 16245 VINEYARD BLVD. Morgan Hill, CA 95037 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-08-30 |
Decision Date | 2004-11-24 |
Summary: | summary |