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 Computer, Diagnostic, Programmable
510(k) Number K954395
Device Name CARTO SYSTEM
Applicant
Biosense, Ltd.
Einstien Bldg., Etgar St.
New Industrial Zone
Tirat Hacarmel,  IL 39101
Applicant Contact SUSAN J ZACHMAN
Correspondent
Biosense, Ltd.
Einstien Bldg., Etgar St.
New Industrial Zone
Tirat Hacarmel,  IL 39101
Correspondent Contact SUSAN J ZACHMAN
Regulation Number870.1425
Classification Product Code
DQK  
Date Received09/20/1995
Decision Date 12/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-