• 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 insufflator, hysteroscopic
510(k) Number K031213
Device Name AQUASENS FLUID MONITORING SYSTEM
Applicant
DAVOL, INC.
SUBSIDIARY OF C.R. BARD
100 SOCKANOSSETT CROSSROAD
CRANSTON,  RI  02920
Applicant Contact BRIAN A KANERVIKO
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number884.1700
Classification Product Code
HIG  
Date Received04/17/2003
Decision Date 04/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
-
-