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FDA 510(k)

OLYMPIC BRAINZ MONITOR MODEL OBM70001

K-Number: K093949 · 2010-06-16

ApplicantNatus Medical, Inc.
Decision Date2010-06-16
Product CodeOMA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OLYMPIC BRAINZ MONITOR MODEL OBM70001 is the device name listed in this FDA 510(k) record. The listed applicant is Natus Medical, Inc.. It received FDA 510(k) clearance on 2010-06-16 under 510(k) number K093949. 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 OLYMPIC BRAINZ MONITOR MODEL OBM70001?

OLYMPIC BRAINZ MONITOR MODEL OBM70001 is a medical device that received FDA 510(k) clearance on 2010-06-16. The listed applicant is Natus Medical, Inc.. The 510(k) number is K093949.

When did OLYMPIC BRAINZ MONITOR MODEL OBM70001 receive FDA 510(k) clearance?

OLYMPIC BRAINZ MONITOR MODEL OBM70001 received FDA 510(k) clearance on 2010-06-16, under 510(k) number K093949.

Who is the listed applicant for OLYMPIC BRAINZ MONITOR MODEL OBM70001?

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

What is the FDA product code for OLYMPIC BRAINZ MONITOR MODEL OBM70001?

The FDA product code for OLYMPIC BRAINZ MONITOR MODEL OBM70001 is OMA.

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Other records listing Natus Medical, Inc. 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.

K093304PROTEKTOR 32K090019NATUS NEUROWORKS, MODEL 104196K083371NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)K073665ALGO 5 NEWBORN HEARING SCREENERK051869NEOBLUE COZY LED PHOTOTHERAPY SYSTEMK030823ALGO 3I NEWBORN HEARING SCREENER

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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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