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, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K100989
Device Name ZURA TEE SYSTEM WITH CLARITEE PROBE
Applicant
Imacor, Inc.
50 Charles Lindbergh Blvd.
Suite 200
Uniondale,  NY  11553
Applicant Contact RICHARD LANZILLOTTO
Correspondent
Imacor, Inc.
50 Charles Lindbergh Blvd.
Suite 200
Uniondale,  NY  11553
Correspondent Contact RICHARD LANZILLOTTO
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/09/2010
Decision Date 06/25/2010
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
Recalls CDRH Recalls
-
-