The following data is part of a premarket notification filed by Barco Nv Display Systems with the FDA for Barco Medis 5mp 5 Megapixel Medical Diagnostic Display System.
Device ID | K982820 |
510k Number | K982820 |
Device Name: | BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEM |
Classification | System, Image Processing, Radiological |
Applicant | BARCO NV DISPLAY SYSTEMS P.O. BOX 9169 Chico, CA 95927 -9169 |
Contact | Frank Ferguson |
Correspondent | Frank Ferguson BARCO NV DISPLAY SYSTEMS P.O. BOX 9169 Chico, CA 95927 -9169 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-11 |
Decision Date | 1998-10-08 |
Summary: | summary |