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 Plethysmograph, Impedance
510(k) Number K032491
Device Name ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR
Applicant
IMAGYN MEDICAL TECHNOLOGIES, INC.
1 PARK PLAZA, SUITE 1100
IRVINE,  CA  92614
Applicant Contact JULIE POWELL
Correspondent
IMAGYN MEDICAL TECHNOLOGIES, INC.
1 PARK PLAZA, SUITE 1100
IRVINE,  CA  92614
Correspondent Contact JULIE POWELL
Regulation Number870.2770
Classification Product Code
DSB  
Date Received08/12/2003
Decision Date 09/04/2003
Decision SE - With Limitations (SESU)
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
-
-