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FDA 510(k)

HBIDB - HUMAN BRIAN INDEX SOFTWARE

K-Number: K112077 · 2012-03-09

ApplicantCorscience GmbH & Co. KG
Decision Date2012-03-09
Product CodeOLU
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HBIDB - HUMAN BRIAN INDEX SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Corscience GmbH & Co. KG. It received FDA 510(k) clearance on 2012-03-09 under 510(k) number K112077. 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 HBIDB - HUMAN BRIAN INDEX SOFTWARE?

HBIDB - HUMAN BRIAN INDEX SOFTWARE is a medical device that received FDA 510(k) clearance on 2012-03-09. The listed applicant is Corscience GmbH & Co. KG. The 510(k) number is K112077.

When did HBIDB - HUMAN BRIAN INDEX SOFTWARE receive FDA 510(k) clearance?

HBIDB - HUMAN BRIAN INDEX SOFTWARE received FDA 510(k) clearance on 2012-03-09, under 510(k) number K112077.

Who is the listed applicant for HBIDB - HUMAN BRIAN INDEX SOFTWARE?

The FDA 510(k) record lists Corscience GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HBIDB - HUMAN BRIAN INDEX SOFTWARE?

The FDA product code for HBIDB - HUMAN BRIAN INDEX SOFTWARE is OLU.

Related Clinical Trials

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Other records listing Corscience GmbH & Co. KG as applicant

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.

K193159NeuroAmp II, NeuroAmp II.5sK082077BT3/6, BT12K073557EEG NEUROAMP, MODEL CS10137

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.K202588BNA PlatformElminda, Ltd.K191432cortiQ PROG.Tec Medical Engineering GmbH

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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