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FDA 510(k)

NIHON KOHDEN ELECTROCARDIOGRAPH

K-Number: K813266 · 1982-01-29

ApplicantNihon Kohden America, Inc.
Decision Date1982-01-29
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NIHON KOHDEN ELECTROCARDIOGRAPH 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 1982-01-29 under 510(k) number K813266. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIHON KOHDEN ELECTROCARDIOGRAPH?

NIHON KOHDEN ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1982-01-29. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K813266.

When did NIHON KOHDEN ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

NIHON KOHDEN ELECTROCARDIOGRAPH received FDA 510(k) clearance on 1982-01-29, under 510(k) number K813266.

Who is the listed applicant for NIHON KOHDEN ELECTROCARDIOGRAPH?

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 NIHON KOHDEN ELECTROCARDIOGRAPH?

The FDA product code for NIHON KOHDEN ELECTROCARDIOGRAPH is DRS.

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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: DRS)

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.

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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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