The following data is part of a premarket notification filed by Barco Nv with the FDA for Mfcd 2320.
Device ID | K040158 |
510k Number | K040158 |
Device Name: | MFCD 2320 |
Classification | System, Image Processing, Radiological |
Applicant | BARCO NV 12200 ACADEMY ROAD NE, # 931 Albuquerque, NM 87111 |
Contact | Frank Ferguson |
Correspondent | Frank Ferguson BARCO NV 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 | 2004-01-23 |
Decision Date | 2004-04-12 |
Summary: | summary |