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 Cabinet, X-Ray System
510(k) Number K210956
Device Name Kubtec Mozart (XPERT42)
Applicant
KUB Technologies, Inc.
111 Research Drive
Stratford,  CT  06615
Applicant Contact Chester Lowe
Correspondent
KUB Technologies, Inc.
111 Research Drive
Stratford,  CT  06615
Correspondent Contact Chester Lowe
Regulation Number892.1680
Classification Product Code
MWP  
Date Received03/30/2021
Decision Date 08/31/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-