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FDA 510(k)

EEG-4300 W/OPTINAL ACCESS. EEG 4314 &

K-Number: K842714 · 1984-09-25

ApplicantNihon Kohden America, Inc.
Decision Date1984-09-25
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EEG-4300 W/OPTINAL ACCESS. EEG 4314 & 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 1984-09-25 under 510(k) number K842714. 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 EEG-4300 W/OPTINAL ACCESS. EEG 4314 &?

EEG-4300 W/OPTINAL ACCESS. EEG 4314 & is a medical device that received FDA 510(k) clearance on 1984-09-25. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K842714.

When did EEG-4300 W/OPTINAL ACCESS. EEG 4314 & receive FDA 510(k) clearance?

EEG-4300 W/OPTINAL ACCESS. EEG 4314 & received FDA 510(k) clearance on 1984-09-25, under 510(k) number K842714.

Who is the listed applicant for EEG-4300 W/OPTINAL ACCESS. EEG 4314 &?

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 EEG-4300 W/OPTINAL ACCESS. EEG 4314 &?

The FDA product code for EEG-4300 W/OPTINAL ACCESS. EEG 4314 & 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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