The following data is part of a premarket notification filed by Livermoretech Inc. with the FDA for Lavid Fmts Diagnostic X-ray System.
Device ID | K180663 |
510k Number | K180663 |
Device Name: | LaVid FMTS DIAGNOSTIC X-RAY SYSTEM |
Classification | System, X-ray, Stationary |
Applicant | LIVERMORETECH Inc. 801 North Jupiter Rd, Suite 200 Plano, TX 75074 |
Contact | Jae Hong Kim |
Correspondent | Dave Kim Mtech Group 8310 Buffalo Speedway Houston, TX 75074 |
Product Code | KPR |
CFR Regulation Number | 892.1680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-03-14 |
Decision Date | 2018-05-18 |