• 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 Device, Fertility Diagnostic, Proceptive
510(k) Number K122337
FOIA Releasable 510(k) K122337
Device Name OVUSENSE
Applicant
FERTILITY FOCUS LTD
717 LAKEGLEN DRIVE
SUWANEE,  GA  30024
Applicant Contact PENNY NORTHCUTT
Correspondent
FERTILITY FOCUS LTD
717 LAKEGLEN DRIVE
SUWANEE,  GA  30024
Correspondent Contact PENNY NORTHCUTT
Classification Product Code
LHD  
Date Received08/02/2012
Decision Date 08/06/2013
Decision Substantially Equivalent (SESE)
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-