The following data is part of a premarket notification filed by Barco Nv Display Systems with the FDA for Barco Mgd 521 5 Megapixel Diagnostic Display.
Device ID | K980541 |
510k Number | K980541 |
Device Name: | BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY |
Classification | System, Digital Image Communications, Radiological |
Applicant | BARCO NV DISPLAY SYSTEMS 3407 BAY AVE. Chico, CA 95973 |
Contact | Frank Ferguson |
Correspondent | Frank Ferguson BARCO NV DISPLAY SYSTEMS 3407 BAY AVE. Chico, CA 95973 |
Product Code | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-02-11 |
Decision Date | 1998-04-09 |
Summary: | summary |