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FDA 510(k)

LIFESCAN EEG MONITOR

K-Number: K841790 · 1984-07-12

ApplicantNeurometrics
Decision Date1984-07-12
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LIFESCAN EEG MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Neurometrics. It received FDA 510(k) clearance on 1984-07-12 under 510(k) number K841790. 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 LIFESCAN EEG MONITOR?

LIFESCAN EEG MONITOR is a medical device that received FDA 510(k) clearance on 1984-07-12. The listed applicant is Neurometrics. The 510(k) number is K841790.

When did LIFESCAN EEG MONITOR receive FDA 510(k) clearance?

LIFESCAN EEG MONITOR received FDA 510(k) clearance on 1984-07-12, under 510(k) number K841790.

Who is the listed applicant for LIFESCAN EEG MONITOR?

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

What is the FDA product code for LIFESCAN EEG MONITOR?

The FDA product code for LIFESCAN EEG 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 Neurometrics 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.

K861900LIFESCAN EVOKED POTENTIAL SYSTEMK800452NEUROMETRICS 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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