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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name uterine electromyographic monitor
510(k) Number K142583
Device Name LaborView LV1000
Applicant
OBMedical Company
107 SW 140th Terrace, Suite 1
Newberry,  FL  32669
Applicant Contact Suha Jhaveri
Correspondent
PROMEDIC, INC.
107 SW 140TH TERRACE, 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
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