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 Catheter, Intravascular, Diagnostic
510(k) Number K022004
Device Name CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1
Applicant
Biosensors International-USA
20250 Acacia St., Suite 115
Newport Beach,  CA  92660
Applicant Contact JORGE HAIDER
Correspondent
Biosensors International-USA
20250 Acacia St., Suite 115
Newport Beach,  CA  92660
Correspondent Contact JORGE HAIDER
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/19/2002
Decision Date 03/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-