The following data is part of a premarket notification filed by Barco Nv Barcoview with the FDA for Mgd 2621l Medical Greyscale Display.
Device ID | K033103 |
510k Number | K033103 |
Device Name: | MGD 2621L MEDICAL GREYSCALE DISPLAY |
Classification | System, Image Processing, Radiological |
Applicant | BARCO NV BARCOVIEW 12200 ACADEMY ROAD NE # 931 Albuquerque, NM 87111 |
Contact | Frank Ferguson |
Correspondent | Frank Ferguson BARCO NV BARCOVIEW 12200 ACADEMY ROAD NE # 931 Albuquerque, NM 87111 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-29 |
Decision Date | 2004-04-16 |
Summary: | summary |