LaborView LV1000 Wireless Electrode System— 510(k) K190798

Name: FDA 510(k) clearance K190798
Creator: U.S. Food and Drug Administration
Published: 2020-09-18

Substantially Equivalent

Obmedical Company

FDA 510(k) clearance K190798 for LaborView LV1000 Wireless Electrode System, Substantially Equivalent on 2020-09-18. Applicant: Obmedical Company. Device class: 2.

Clearance details

Applicant: Obmedical Company
Product code: Code OSP
Device class: Class 2
Regulation: 21 CFR 884.2720
Advisory panel: Obstetrics/Gynecology
Date received: 2019-03-28
Decision date: 2020-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OSP

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K153262 — PUREtrace2017-02-07
K142583 — LaborView LV10002015-01-16
K140862 — MONICA NOVII WIRELESS PATCH SYSTEM2014-08-27
K131889 — EUM 100PRO2014-04-23
K130002 — SURECALL LABOR MONITOR2013-06-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.