BRM3 Brain Monitor

Q: When was BRM3 Brain Monitor cleared by the FDA?

BRM3 Brain Monitor (K071449) received a 510(k) decision of Substantially Equivalent on September 14, 2007, 113 days after the submission was received.

Q: What is the product code of K071449?

The FDA product code is OMA – Amplitude-Integrated Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.

FDA 510(k) K071449 · Brainz Instruments , Ltd.

Substantially Equivalent

510(k) numberK071449

Submission

Device name: BRM3 Brain Monitor
Applicant: Brainz Instruments , Ltd.
Auckland, NZ
Received: May 24, 2007
Decision date: September 14, 2007
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Third-party review: Yes

Official FDA 510(k) record

Device classification

Product code: OMA – Amplitude-Integrated Electroencephalograph
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.1400
Specialty: Neurology

Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).

Other 510(k)s with product code OMA

510(k)	Device	Applicant	Decision
K192889	NeoOMA · Traditional	Eemagine Medical Imaging Solutions GmbH	01/30/2020SE
K163644	Nihon Kohden QP-160AK EEG Trend ProgramOMA · Traditional	Nihon Kohden Corporation	05/19/2017SE
K161027	Cadwell AmpliScanOMA · Traditional	Cadwell Industries, Inc.	11/08/2016SE
K152301	Background Pattern Classification [BPc(TM)]OMA · Traditional	Natus Medical Incorporated Dba Excel-Tech Ltd.…	06/03/2016SE
K130238	Nihon Kohden AE-918P Neuro UnitOMA · Traditional	Nihon Kohden Corp.	03/04/2015SE
K131789	Cerebralogik- AeegOMA · Traditional	Mennen Medical , Ltd.	12/27/2013SE
K123079	Olympic Brainz MonitorOMA · Traditional	Excel-Tech Ltd. (Xltek)	05/08/2013SE
K120485	Nihon Kohden QP-160 Ak Trend Program with the Addition of Dsa Asymmetry Trend and FFT POMA · Special	Nihon Kohden America, Inc.	03/16/2012SE
K092573	Nihon Kohden QP-160AK EEG Trend ProgramOMA · Traditional	Nihon Kohden America, Inc.	07/09/2010SE
K093949	Olympic Brainz Monitor Model OBM70001OMA · Traditional	Natus Medical, Inc.	06/16/2010SE

More from Natus Medical, Inc.

510(k)	Device	Decision
K033010	BRM2 Brain MonitorOLT · Traditional	10/10/2003SE
K030489	BRM2 Brain MonitorOLT · Traditional	05/02/2003SE

Questions and answers

When was BRM3 Brain Monitor cleared by the FDA?

BRM3 Brain Monitor (K071449) received a 510(k) decision of Substantially Equivalent on September 14, 2007, 113 days after the submission was received.

What is the product code of K071449?

The FDA product code is OMA – Amplitude-Integrated Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.