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FDA 510(k)

YuGo System

K-Number: K151955 · 2016-02-05

ApplicantBiogaming , Ltd.
Decision Date2016-02-05
Product CodeLXJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

YuGo System is the device name listed in this FDA 510(k) record. The listed applicant is Biogaming , Ltd.. It received FDA 510(k) clearance on 2016-02-05 under 510(k) number K151955. The device is classified under product code LXJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the YuGo System?

YuGo System is a medical device that received FDA 510(k) clearance on 2016-02-05. The listed applicant is Biogaming , Ltd.. The 510(k) number is K151955.

When did YuGo System receive FDA 510(k) clearance?

YuGo System received FDA 510(k) clearance on 2016-02-05, under 510(k) number K151955.

Who is the listed applicant for YuGo System?

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

What is the FDA product code for YuGo System?

The FDA product code for YuGo System is LXJ.

Related Devices (Code: LXJ)

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.

K192474VERAReflexion Health, Inc.K182333VeraReflexion Health, Inc.K180880DARI HealthScientific Analytics, Inc.K171547Qualisys Clinical SystemQualisys ABK173931MindMotion(TM) GOMindmaze SAK172882UINCARE HOMEUincare Corp.

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.

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