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

FDA 510(k)

BNA Platform

K-Number: K202588 · 2020-12-07

ApplicantElminda, Ltd.
Decision Date2020-12-07
Product CodeOLU
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BNA Platform is the device name listed in this FDA 510(k) record. The listed applicant is Elminda, Ltd.. It received FDA 510(k) clearance on 2020-12-07 under 510(k) number K202588. The device is classified under product code OLU. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BNA Platform?

BNA Platform is a medical device that received FDA 510(k) clearance on 2020-12-07. The listed applicant is Elminda, Ltd.. The 510(k) number is K202588.

When did BNA Platform receive FDA 510(k) clearance?

BNA Platform received FDA 510(k) clearance on 2020-12-07, under 510(k) number K202588.

Who is the listed applicant for BNA Platform?

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

What is the FDA product code for BNA Platform?

The FDA product code for BNA Platform is OLU.

Related Devices (Code: OLU)

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.

K253015Cognitive Function Neuroimaging (cfNI) Software (1.0.0)VoxNeuro, Inc.K240420NeuroField Analysis SuiteNeurofield, Inc.K222838iSyncBrain©-CiMediSync, Inc.K212684BrainView QEEG SoftwareMedeia, Inc.K191432cortiQ PROG.Tec Medical Engineering GmbHK171414qEEG-ProBrainmaster Technologies, Inc.

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.

↑