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 Uterine Electromyographic Monitor
510(k) Number K142583
Device Name LaborView LV1000
Applicant
Obmedical Company
107 SW 140th Ter.
Suite #1
Newberry,  FL  32669
Applicant Contact Suha Jhaveri
Correspondent
Promedic, Inc.
107 SW 140th Ter.
Suite #1
Newberry,  FL  32669
Correspondent Contact PAUL DRYDEN
Regulation Number884.2720
Classification Product Code
OSP  
Subsequent Product Code
HGM  
Date Received09/15/2014
Decision Date 01/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT01400880
NCT02024165
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-