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FDA 510(k)

SPECTRAL EEG MONITOR MODEL B500

K-Number: K913051 · 1991-08-20

ApplicantBiometrak Corp.
Decision Date1991-08-20
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPECTRAL EEG MONITOR MODEL B500 is the device name listed in this FDA 510(k) record. The listed applicant is Biometrak Corp.. It received FDA 510(k) clearance on 1991-08-20 under 510(k) number K913051. 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 SPECTRAL EEG MONITOR MODEL B500?

SPECTRAL EEG MONITOR MODEL B500 is a medical device that received FDA 510(k) clearance on 1991-08-20. The listed applicant is Biometrak Corp.. The 510(k) number is K913051.

When did SPECTRAL EEG MONITOR MODEL B500 receive FDA 510(k) clearance?

SPECTRAL EEG MONITOR MODEL B500 received FDA 510(k) clearance on 1991-08-20, under 510(k) number K913051.

Who is the listed applicant for SPECTRAL EEG MONITOR MODEL B500?

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

What is the FDA product code for SPECTRAL EEG MONITOR MODEL B500?

The FDA product code for SPECTRAL EEG MONITOR MODEL B500 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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