LaborView™ LV1000 Wireless Electrode System

Uterine Electromyographic Monitor

OBMedical Company

The following data is part of a premarket notification filed by Obmedical Company with the FDA for Laborview™ Lv1000 Wireless Electrode System.

Pre-market Notification Details

Device IDK190798
510k NumberK190798
Device Name:LaborView™ LV1000 Wireless Electrode System
ClassificationUterine Electromyographic Monitor
Applicant OBMedical Company 3630 SW 47th Ave, Suite 201 Gainesville,  FL  32608
ContactMark A. Samuels
CorrespondentPaul Dryden
OBMedical Company 3630 SW 47th Ave, Suite 201 Gainesville,  FL  32608
Product CodeOSP  
CFR Regulation Number884.2720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-28
Decision Date2020-09-18

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