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 Device, Fertility Diagnostic, Proceptive
510(k) Number K844043
Device Name OVUDATE
Applicant
Joel R.L. Ehren Kranz
60 Franklin St.
Morristown,  NJ  07960
Correspondent
Joel R.L. Ehren Kranz
60 Franklin St.
Morristown,  NJ  07960
Classification Product Code
LHD  
Date Received10/17/1984
Decision Date 02/15/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-