The following data is part of a premarket notification filed by Vortech Data, Inc. with the FDA for Vortech 3m Network Printing.
Device ID | K914834 |
510k Number | K914834 |
Device Name: | VORTECH 3M NETWORK PRINTING |
Classification | Camera, Multi Format, Radiological |
Applicant | VORTECH DATA, INC. 2929 NORTH CENTRAL EXPRESSWAY SUITE 101 Richardson, TX 75080 |
Contact | Kem Myers |
Correspondent | Kem Myers VORTECH DATA, INC. 2929 NORTH CENTRAL EXPRESSWAY SUITE 101 Richardson, TX 75080 |
Product Code | LMC |
CFR Regulation Number | 892.2040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-25 |
Decision Date | 1992-03-06 |