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FDA 510(k)

NEUROFAX 7310 SERIES (EEG)

K-Number: K854663 · 1986-08-20

ApplicantNihon Kohden America, Inc.
Decision Date1986-08-20
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROFAX 7310 SERIES (EEG) 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 1986-08-20 under 510(k) number K854663. 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 NEUROFAX 7310 SERIES (EEG)?

NEUROFAX 7310 SERIES (EEG) is a medical device that received FDA 510(k) clearance on 1986-08-20. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K854663.

When did NEUROFAX 7310 SERIES (EEG) receive FDA 510(k) clearance?

NEUROFAX 7310 SERIES (EEG) received FDA 510(k) clearance on 1986-08-20, under 510(k) number K854663.

Who is the listed applicant for NEUROFAX 7310 SERIES (EEG)?

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 NEUROFAX 7310 SERIES (EEG)?

The FDA product code for NEUROFAX 7310 SERIES (EEG) 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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