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FDA 510(k)

ELECTROENCEPHALOGRAPH ECG-6151

K-Number: K820067 · 1982-02-12

ApplicantNihon Kohden America, Inc.
Decision Date1982-02-12
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTROENCEPHALOGRAPH ECG-6151 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 1982-02-12 under 510(k) number K820067. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROENCEPHALOGRAPH ECG-6151?

ELECTROENCEPHALOGRAPH ECG-6151 is a medical device that received FDA 510(k) clearance on 1982-02-12. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K820067.

When did ELECTROENCEPHALOGRAPH ECG-6151 receive FDA 510(k) clearance?

ELECTROENCEPHALOGRAPH ECG-6151 received FDA 510(k) clearance on 1982-02-12, under 510(k) number K820067.

Who is the listed applicant for ELECTROENCEPHALOGRAPH ECG-6151?

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 ELECTROENCEPHALOGRAPH ECG-6151?

The FDA product code for ELECTROENCEPHALOGRAPH ECG-6151 is DPS.

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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: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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