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FDA 510(k)

BRM3 BRAIN MONITOR

K-Number: K071449 · 2007-09-14

ApplicantBrainz Instruments , Ltd.
Decision Date2007-09-14
Product CodeOMA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BRM3 BRAIN MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Brainz Instruments , Ltd.. It received FDA 510(k) clearance on 2007-09-14 under 510(k) number K071449. The device is classified under product code OMA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRM3 BRAIN MONITOR?

BRM3 BRAIN MONITOR is a medical device that received FDA 510(k) clearance on 2007-09-14. The listed applicant is Brainz Instruments , Ltd.. The 510(k) number is K071449.

When did BRM3 BRAIN MONITOR receive FDA 510(k) clearance?

BRM3 BRAIN MONITOR received FDA 510(k) clearance on 2007-09-14, under 510(k) number K071449.

Who is the listed applicant for BRM3 BRAIN MONITOR?

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

What is the FDA product code for BRM3 BRAIN MONITOR?

The FDA product code for BRM3 BRAIN MONITOR is OMA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Brainz Instruments , Ltd. 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.

K033010BRM2 BRAIN MONITORK030489BRM2 BRAIN MONITOR

Related Devices (Code: OMA)

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.

K192889NeoEemagine Medical Imaging Solutions GmbHK163644Nihon Kohden QP-160AK EEG Trend ProgramNihon Kohden CorporationK161027Cadwell AmpliScanCadwell Industries, Inc.K152301Background Pattern Classification [BPc(TM)]Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K131789CEREBRALOGIK- AEEGMennen Medical , Ltd.K123079OLYMPIC BRAINZ MONITORExcel-Tech Ltd. (Xltek)

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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