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FDA 510(k)

CARDIOFAX Q ECG-8420A

K-Number: K922394 · 1994-03-01

ApplicantNihon Kohden America, Inc.
Decision Date1994-03-01
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

CARDIOFAX Q ECG-8420A 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 1994-03-01 under 510(k) number K922394. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOFAX Q ECG-8420A?

CARDIOFAX Q ECG-8420A is a medical device that received FDA 510(k) clearance on 1994-03-01. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K922394.

When did CARDIOFAX Q ECG-8420A receive FDA 510(k) clearance?

CARDIOFAX Q ECG-8420A received FDA 510(k) clearance on 1994-03-01, under 510(k) number K922394.

Who is the listed applicant for CARDIOFAX Q ECG-8420A?

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 CARDIOFAX Q ECG-8420A?

The FDA product code for CARDIOFAX Q ECG-8420A is LOS.

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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: LOS)

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.

K090895EKG-PLUS II SOFTWAREBionet Co., Ltd.K083749CARDIOVIEW32 REVIEW MODULEQrs Diagnostic, LLCK073376PHILIPS ECG ALGORITHMPhilips Medical SystemsK023034CARDIOTOUCH-3000Bionet Company, Ltd.K011328CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPHBionet Company, Ltd.K993616CARDIO-CARD INTERPRETATION SYSTEM INasiff Assoc., 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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