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FDA 510(k)

COMPUMEDICS E-SERIES EEG SYSTEM

K-Number: K000068 · 2000-03-13

ApplicantCompumedics Neuro Science Pty , Ltd.
Decision Date2000-03-13
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

COMPUMEDICS E-SERIES EEG SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Compumedics Neuro Science Pty , Ltd.. It received FDA 510(k) clearance on 2000-03-13 under 510(k) number K000068. 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 COMPUMEDICS E-SERIES EEG SYSTEM?

COMPUMEDICS E-SERIES EEG SYSTEM is a medical device that received FDA 510(k) clearance on 2000-03-13. The listed applicant is Compumedics Neuro Science Pty , Ltd.. The 510(k) number is K000068.

When did COMPUMEDICS E-SERIES EEG SYSTEM receive FDA 510(k) clearance?

COMPUMEDICS E-SERIES EEG SYSTEM received FDA 510(k) clearance on 2000-03-13, under 510(k) number K000068.

Who is the listed applicant for COMPUMEDICS E-SERIES EEG SYSTEM?

The FDA 510(k) record lists Compumedics Neuro Science Pty , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPUMEDICS E-SERIES EEG SYSTEM?

The FDA product code for COMPUMEDICS E-SERIES EEG SYSTEM is OLT.

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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

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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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