NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES

K961272 · Nihon Kohden America, Inc. · LOS · Nov 1, 1996 · CV

Device Facts

• Record ID: K961272
• Device Name: NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES
• Applicant: Nihon Kohden America, Inc.
• Product Code: LOS · CV
• Decision Date: Nov 1, 1996
• Decision: SESE
• Submission Type: Traditional

Indications for Use

Nihon Kohden's Cardiofax, model number ECG-9320A, is intended for medical purposes used to process the electrical signals transmitted through two or more electrocardiograph electrodes and to produce a visual display and prepare a record of the electrical signals produced by the heart. This product will be available for use by a physician within the hospital, laboratory, clinic or in a remote environment under the direct supervision of a physician.

Device Story

ECG-9320A Cardiofax; electrocardiograph device. Inputs: electrical signals from electrodes attached to patient. Processing: acquisition, signal processing, display, and recording of cardiac electrical activity. Output: visual display and hard-copy record of ECG waveforms. Setting: hospital, clinic, laboratory, or remote environment. Operator: physician. Benefit: facilitates cardiac rhythm assessment and diagnostic documentation.

Clinical Evidence

Bench testing only. Electromagnetic, environmental, safety, and performance testing conducted. Software validation performed for acquisition, processing, display, and recording functions. Results confirmed device performance within specifications.

Technological Characteristics

Electrocardiograph; processes electrical signals from electrodes. Includes software for signal acquisition, processing, display, and recording. Device subject to electromagnetic, environmental, and safety testing.

Indications for Use

Indicated for patients requiring electrocardiographic monitoring and recording of heart electrical signals. Intended for use by physicians in hospitals, clinics, laboratories, or remote settings under physician supervision.

Predicate Devices

• Nihon Kohden Cardiofax, ECG-8340A Electrocardiograph (K865032)
• Hewlett-Packard M1700A PageWriter XLi Cardiograph (K895520)

Submission Summary (Full Text)

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NIHON KOHDEN AMERICA, INC.
April 1, 1996
510(k) NOTIFICATION
ECG-9320A CARDIOFAX
NOV - 1 1996
K961272

Name and Address of Applicant
Nihon Kohden America, Inc.
2601 Campus Drive
Irvine, California 92715-1601

Contact Person and Telephone
Mr. Gary Reasoner
Director of Technical Operations
[phone] ext 3387

The device has been classified as Class II by the Division of Cardiovascular, Respiratory, and Neurological Devices and the Cardiovascular Device Classification Panel under 21 CFR Part 870.2340 "Electrocardiograph" as per part 74 DPS, 21 CFR.

Common names for the ECG-9320A Cardiofax device include electrocardiograph and Cardiograph.

The predicate devices are the Nihon Kohden Cardiofax, ECG-8340A Electrocardiograph per 510(k) #K865032, commercial distribution certification dated March 10, 1987 and the Hewlett-Packard M1700A PageWriter XLi Cardiograph per 510(k) #K895520, commercial distribution certification dated July 17, 1990

Nihon Kohden's Cardiofax, model number ECG-9320A, is intended for medical purposes used to process the electrical signals transmitted through two or more electrocardiograph electrodes and to produce a visual display and prepare a record of the electrical signals produced by the heart. This product will be available for use by a physician within the hospital, laboratory, clinic or in a remote environment under the direct supervision of a physician.

To date, no performance standards or special controls are known or established for this device as required by Section 514 of the Food, Drug and Cosmetic Act and implemented by 21 CFR Part 861.

The ECG-9320A Cardiofax device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software functions of acquiring, processing, displaying and recording of all functions of the device. The results confirmed that the device performed within specifications.

Therefore based on the above, Nihon Kohden believes that the ECG-9320A Cardiofax is substantially equivalent to the Nihon Kohden ECG-8340A Cardiofax and the Hewlett-Packard M1700A PageWriter XLi cardiograph.

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