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 monitor, uterine contraction, external (for use in clinic)
510(k) Number K061044
Device Name FEATHERLITE AQUA TOCODYNAMOMETER
Applicant
VENTREX, INC.
3007 BUNSEN AVE.
SUITE K
VENTURA,  CA  93003
Applicant Contact GEORGE AUSTRIA
Correspondent
VENTREX, INC.
3007 BUNSEN AVE.
SUITE K
VENTURA,  CA  93003
Correspondent Contact GEORGE AUSTRIA
Regulation Number884.2720
Classification Product Code
HFM  
Date Received04/14/2006
Decision Date 07/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-