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FDA 510(k)

EMG MODULES FOR POLYGRAPH SYSTEM

K-Number: K823562 · 1983-01-14

ApplicantNihon Kohden America, Inc.
Decision Date1983-01-14
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EMG MODULES FOR POLYGRAPH SYSTEM 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 1983-01-14 under 510(k) number K823562. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMG MODULES FOR POLYGRAPH SYSTEM?

EMG MODULES FOR POLYGRAPH SYSTEM is a medical device that received FDA 510(k) clearance on 1983-01-14. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K823562.

When did EMG MODULES FOR POLYGRAPH SYSTEM receive FDA 510(k) clearance?

EMG MODULES FOR POLYGRAPH SYSTEM received FDA 510(k) clearance on 1983-01-14, under 510(k) number K823562.

Who is the listed applicant for EMG MODULES FOR POLYGRAPH SYSTEM?

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 EMG MODULES FOR POLYGRAPH SYSTEM?

The FDA product code for EMG MODULES FOR POLYGRAPH SYSTEM is IKN.

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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: IKN)

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.

K172743Natus VikingQuestNatus Neurology IncorporatedK163150ViMove2Dorsavi, Ltd.K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLCK123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.K113074CMAP PROMedical Technologies, 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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