Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, X-Ray, Mobile
510(k) Number K203667
Device Name EzRay M (Model: VMX-P300)
Applicant
VATECH Co., Ltd.
13, Samsung 1-Ro 2-Gil
Hwaseong-Si,  KR 18449
Applicant Contact Daniel Kim
Correspondent
Mtechgroup
7707 Fannin St., Suite 200-Vlll
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number892.1720
Classification Product Code
IZL  
Date Received12/16/2020
Decision Date 02/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-