FDA 510(k) Application Details - K190798

Device Classification Name	More FDA Info for this Device
510(K) Number	K190798
Device Name	LaborViewÖ LV1000 Wireless Electrode System
Applicant	OBMedical Company 3630 SW 47th Ave, Suite 201 Gainesville, FL 32608 US Other 510(k) Applications for this Company
Contact	Mark A. Samuels Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OSP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2019
Decision Date	09/18/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review