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FDA 510(k)

BRM2 BRAIN MONITOR

K-Number: K033010 · 2003-10-10

ApplicantBrainz Instruments , Ltd.
Decision Date2003-10-10
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BRM2 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 2003-10-10 under 510(k) number K033010. 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 BRM2 BRAIN MONITOR?

BRM2 BRAIN MONITOR is a medical device that received FDA 510(k) clearance on 2003-10-10. The listed applicant is Brainz Instruments , Ltd.. The 510(k) number is K033010.

When did BRM2 BRAIN MONITOR receive FDA 510(k) clearance?

BRM2 BRAIN MONITOR received FDA 510(k) clearance on 2003-10-10, under 510(k) number K033010.

Who is the listed applicant for BRM2 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 BRM2 BRAIN MONITOR?

The FDA product code for BRM2 BRAIN MONITOR is OLT.

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.

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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.

K071449BRM3 BRAIN MONITORK030489BRM2 BRAIN MONITOR

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.

K261712Ceribell EEG Analysis SoftwareCeribell, Inc.K254213Pascall Sensor Unit (PSU1)Pascall Systems, Inc.K253767UB ERP SystemUniversal BrainK251881HippoMind (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.

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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