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FDA 510(k)

AE-800PA EEG MODULE

K-Number: K884537 · 1988-12-29

ApplicantNihon Kohden America, Inc.
Decision Date1988-12-29
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AE-800PA EEG MODULE 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 1988-12-29 under 510(k) number K884537. 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 AE-800PA EEG MODULE?

AE-800PA EEG MODULE is a medical device that received FDA 510(k) clearance on 1988-12-29. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K884537.

When did AE-800PA EEG MODULE receive FDA 510(k) clearance?

AE-800PA EEG MODULE received FDA 510(k) clearance on 1988-12-29, under 510(k) number K884537.

Who is the listed applicant for AE-800PA EEG MODULE?

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 AE-800PA EEG MODULE?

The FDA product code for AE-800PA EEG MODULE 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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