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510(k) K190798

Device
LaborView™ LV1000 Wireless Electrode System
Applicant
OBMedical Company
510(k) number
K190798
Product code
OSP  
Decision
Substantially Equivalent (SESE)
Decision date
2020-09-18
Date received
2019-03-28
Regulation
884.2720
Classification name
Uterine Electromyographic Monitor
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Mark A. Samuels
Address
3630 SW 47th Ave., Suite 201 Gainesville FL US 32608 32608

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OSP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K153262PUREtrace™Nemo Healthcare BV2017-02-07
K142583LaborView LV1000Obmedical Company2015-01-16
K140862MONICA NOVII WIRELESS PATCH SYSTEMMonica Healthcare, Ltd.2014-08-27
K131889EUM 100PROPromedic, Inc.2014-04-23
K130002SURECALL LABOR MONITORReproductive Research Technologies, LP2013-06-28
K112390MONICA AN24Monica Healthcare, Ltd.2012-07-13
K112163MONICA IF24Monica Healthcare2011-08-30
K101801MONICA AN24Monica Healthcare2011-02-03
K090145SURECALL EMG LABOR MONITORReproductive Research Technologies, LP2011-01-25

Legacy Summary#

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FDA Review#

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