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FDA 510(k)

WLECTROCARDIOGRAPH ECG-7204

K-Number: K831274 · 1983-10-27

ApplicantNihon Kohden America, Inc.
Decision Date1983-10-27
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WLECTROCARDIOGRAPH ECG-7204 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 1983-10-27 under 510(k) number K831274. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WLECTROCARDIOGRAPH ECG-7204?

WLECTROCARDIOGRAPH ECG-7204 is a medical device that received FDA 510(k) clearance on 1983-10-27. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K831274.

When did WLECTROCARDIOGRAPH ECG-7204 receive FDA 510(k) clearance?

WLECTROCARDIOGRAPH ECG-7204 received FDA 510(k) clearance on 1983-10-27, under 510(k) number K831274.

Who is the listed applicant for WLECTROCARDIOGRAPH ECG-7204?

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 WLECTROCARDIOGRAPH ECG-7204?

The FDA product code for WLECTROCARDIOGRAPH ECG-7204 is DSI.

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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: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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