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FDA 510(k)

ELECTROENCEPHALOGRAPHS EEG-5208,5210

K-Number: K820066 · 1982-02-04

ApplicantNihon Kohden America, Inc.
Decision Date1982-02-04
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELECTROENCEPHALOGRAPHS EEG-5208,5210 is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 1982-02-04 under 510(k) number K820066. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROENCEPHALOGRAPHS EEG-5208,5210?

ELECTROENCEPHALOGRAPHS EEG-5208,5210 is a medical device that received FDA 510(k) clearance on 1982-02-04. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K820066.

When did ELECTROENCEPHALOGRAPHS EEG-5208,5210 receive FDA 510(k) clearance?

ELECTROENCEPHALOGRAPHS EEG-5208,5210 received FDA 510(k) clearance on 1982-02-04, under 510(k) number K820066.

Who is the listed applicant for ELECTROENCEPHALOGRAPHS EEG-5208,5210?

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

What is the FDA product code for ELECTROENCEPHALOGRAPHS EEG-5208,5210?

The FDA product code for ELECTROENCEPHALOGRAPHS EEG-5208,5210 is GWQ.

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Other records listing Nihon Kohden America, 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.

K113117NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOXK120485NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT PK092573NIHON KOHDEN QP-160AK EEG TREND PROGRAMK083456NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970PK083271BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORYK082785NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES

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Related Devices (Code: GWQ)

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.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, 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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