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 system, monitoring, perinatal
510(k) Number K150398
Device Name EUM 100Pro
Applicant
OB TOOLS, LTD.
MIFALEY HAEMEK INDUSTRIAL ZONE
P.O. BOX 667
MIGDAL HA-EMEK,  IL 2310502
Applicant Contact GAL BEN DAVID
Correspondent
PROMEDIC, INC.
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134 -2958
Correspondent Contact PAUL DRYDEN
Regulation Number884.2740
Classification Product Code
HGM  
Subsequent Product Code
OSP  
Date Received02/18/2015
Decision Date 08/06/2015
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
-
-