The following data is part of a premarket notification filed by Barco Nv Display Systems with the FDA for Medis 2mp2 Quad-head Medical Diagnostic Display System.
Device ID | K001751 |
510k Number | K001751 |
Device Name: | MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM |
Classification | System, Image Processing, Radiological |
Applicant | BARCO NV DISPLAY SYSTEMS 8524 VILA LA JOLLA DR. SUITE 161 La Jolla, CA 92037 |
Contact | Frank Ferguson |
Correspondent | Frank Ferguson BARCO NV DISPLAY SYSTEMS 8524 VILA LA JOLLA DR. SUITE 161 La Jolla, CA 92037 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-06-08 |
Decision Date | 2000-07-19 |