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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 the device name listed in this FDA 510(k) record. The listed applicant is Obmedical Company. It received FDA 510(k) clearance on 2020-09-18 under 510(k) 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. The listed applicant is Obmedical Company. The 510(k) number is K190798.

When did LaborView™ LV1000 Wireless Electrode System receive FDA 510(k) clearance?

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

Who is the listed applicant for LaborView™ LV1000 Wireless Electrode System?

The FDA 510(k) record lists Obmedical Company as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: OSP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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