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 Unit, X-Ray, Extraoral With Timer
510(k) Number K984524
Device Name AZTECH 70
Applicant
Villa Sistemi Medicali S.P.A.
1401 Walnut St.
Suite 565
Boulder,  CO  80302
Applicant Contact AL SOSA
Correspondent
Villa Sistemi Medicali S.P.A.
1401 Walnut St.
Suite 565
Boulder,  CO  80302
Correspondent Contact AL SOSA
Regulation Number872.1800
Classification Product Code
EHD  
Date Received12/21/1998
Decision Date 01/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-