Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LaborView™ LV1000 Wireless Electrode System

K-Number: K190798 · 2020-09-18

ApplicantObmedical Company
Decision Date2020-09-18
Product CodeOSP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LaborView™ LV1000 Wireless Electrode System is a medical device manufactured by Obmedical Company. It received FDA 510(k) clearance on 2020-09-18 under approval number K190798. The device is classified under product code OSP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LaborView™ LV1000 Wireless Electrode System?

LaborView™ LV1000 Wireless Electrode System is a medical device that received FDA 510(k) clearance on 2020-09-18. It is manufactured by Obmedical Company. The 510(k) number is K190798.

When was LaborView™ LV1000 Wireless Electrode System approved by the FDA?

LaborView™ LV1000 Wireless Electrode System received FDA 510(k) clearance on 2020-09-18, under approval number K190798.

What company makes LaborView™ LV1000 Wireless Electrode System?

LaborView™ LV1000 Wireless Electrode System is manufactured by Obmedical Company.

What is the FDA product code for LaborView™ LV1000 Wireless Electrode System?

The FDA product code for LaborView™ LV1000 Wireless Electrode System is OSP.

Related Clinical Trials

NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT07608614 Sleep and Performance RECRUITING NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING NCT07603752 Implantable Wireless Brain-Machine Interface System for Spinal Cord Injury: Efficacy and Safety Study RECRUITING NCT05505513 Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback? RECRUITING NCT04956354 The Use of Wireless Sensors in Neonatal Intensive Care ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Related Devices (Code: OSP)

K153262PUREtrace™Nemo Healthcare BV

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑