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 Flowmeter, Blood, Cardiovascular
510(k) Number K041180
Device Name QUANTIX OR VESSEL STABILIZER DEVICE
Applicant
Cardiosonix, Ltd.
Beit Hapa'Amon (Box 124)
20 Hata'As St.,
Kfar Saba,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
Cardiosonix, Ltd.
Beit Hapa'Amon (Box 124)
20 Hata'As St.,
Kfar Saba,  IL 44425
Correspondent Contact AHAVA STEIN
Regulation Number870.2100
Classification Product Code
DPW  
Date Received05/06/2004
Decision Date 06/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-