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, Fluoroscopic, Image-Intensified
510(k) Number K080859
Device Name DRF 4343
Applicant
Villa Sistemi Medicali S.P.A.
Via Delle Azalee 3
Buccinasco,  IT 20090
Applicant Contact PAOLO C SANTIN
Correspondent
Villa Sistemi Medicali S.P.A.
Via Delle Azalee 3
Buccinasco,  IT 20090
Correspondent Contact PAOLO C SANTIN
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Code
MQB  
Date Received03/27/2008
Decision Date 06/04/2008
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
-
-