The following data is part of a premarket notification filed by Cerner Corp. with the FDA for Proview Medical Image Display Module.
Device ID | K000770 |
510k Number | K000770 |
Device Name: | PROVIEW MEDICAL IMAGE DISPLAY MODULE |
Classification | System, Image Processing, Radiological |
Applicant | CERNER CORP. 2800 ROCKCREEK PKWY. Kansas City, MO 64117 |
Contact | Shelley Looby |
Correspondent | Shelley Looby CERNER CORP. 2800 ROCKCREEK PKWY. Kansas City, MO 64117 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-03-09 |
Decision Date | 2000-05-16 |