The following data is part of a premarket notification filed by Cerner Corp. with the FDA for Remote Viewing System Medical Image Display Module.
Device ID | K955000 |
510k Number | K955000 |
Device Name: | REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE |
Classification | System, Digital Image Communications, Radiological |
Applicant | CERNER CORP. 2800 ROCKCREEK PKWY. Kansas City, MO 64117 |
Contact | Paul A Helmut |
Correspondent | Paul A Helmut CERNER CORP. 2800 ROCKCREEK PKWY. Kansas City, MO 64117 |
Product Code | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-01 |
Decision Date | 1996-01-26 |