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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 K190798
Device Name LaborView™ LV1000 Wireless Electrode System
Applicant
Obmedical Company
3630 SW 47th Ave., Suite 201
Gainesville,  FL  32608
Applicant Contact Mark A. Samuels
Correspondent
Obmedical Company
3630 SW 47th Ave., Suite 201
Gainesville,  FL  32608
Correspondent Contact Paul Dryden
Regulation Number884.2720
Classification Product Code
OSP  
Subsequent Product Code
HGM  
Date Received03/28/2019
Decision Date 09/18/2020
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
Predetermined Change
Control Plan Authorized		 No
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