The following data is part of a premarket notification filed by Livermoretech, Inc. with the FDA for E-com Dr-2000 Dr.
Device ID | K193644 |
510k Number | K193644 |
Device Name: | E-COM DR-2000 DR |
Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
Applicant | LiverMoreTech, Inc. 801 North Jupiter Rd, Suite 200, Plano, TX 75074 |
Contact | Jay Kim |
Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
Product Code | MQB |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-12-30 |
Decision Date | 2020-02-14 |