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FDA 510(k)

UB ERP System

K-Number: K253767 · 2026-06-30

ApplicantUniversal Brain
Decision Date2026-06-30
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

UB ERP System is the device name listed in this FDA 510(k) record. The listed applicant is Universal Brain. It received FDA 510(k) clearance on 2026-06-30 under 510(k) number K253767. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UB ERP System?

UB ERP System is a medical device that received FDA 510(k) clearance on 2026-06-30. The listed applicant is Universal Brain. The 510(k) number is K253767.

When did UB ERP System receive FDA 510(k) clearance?

UB ERP System received FDA 510(k) clearance on 2026-06-30, under 510(k) number K253767.

Who is the listed applicant for UB ERP System?

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

What is the FDA product code for UB ERP System?

The FDA product code for UB ERP System is OLT.

Related Devices (Code: OLT)

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.

K251881HippoMind (v1.0)HippoclinicK251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)Nihon Kohden CorporationK240593VEEGix EEG SystemNeuroServo, Inc.K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft , Ltd.K213299Wireless EEG SystemPascall Systems, Inc.K191322E-EEGX, N-EEGXGE Healthcare Finland Oy

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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