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 sound, uterine
510(k) Number K011840
Device Name CERVILENZ UTERINE MEASURING SOUND
Applicant
CERVILENZ INC
2 DELPHINUS
IRVINE,  CA  92612
Applicant Contact JUDY F GORDON
Correspondent
CERVILENZ INC
2 DELPHINUS
IRVINE,  CA  92612
Correspondent Contact JUDY F GORDON
Regulation Number884.4530
Classification Product Code
HHM  
Date Received06/12/2001
Decision Date 08/10/2001
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
-
-