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FDA 510(k)

GUARDIAN, EEG BRAIN MONITORING SYSTEM

K-Number: K874733 · 1988-02-29

ApplicantTracor Northern, Inc.
Decision Date1988-02-29
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GUARDIAN, EEG BRAIN MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tracor Northern, Inc.. It received FDA 510(k) clearance on 1988-02-29 under 510(k) number K874733. 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 GUARDIAN, EEG BRAIN MONITORING SYSTEM?

GUARDIAN, EEG BRAIN MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1988-02-29. The listed applicant is Tracor Northern, Inc.. The 510(k) number is K874733.

When did GUARDIAN, EEG BRAIN MONITORING SYSTEM receive FDA 510(k) clearance?

GUARDIAN, EEG BRAIN MONITORING SYSTEM received FDA 510(k) clearance on 1988-02-29, under 510(k) number K874733.

Who is the listed applicant for GUARDIAN, EEG BRAIN MONITORING SYSTEM?

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

What is the FDA product code for GUARDIAN, EEG BRAIN MONITORING SYSTEM?

The FDA product code for GUARDIAN, EEG BRAIN MONITORING 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

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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