Fukuda Denshi 6-Channel Auto. Electro-
by Brentwood Instruments, Inc. 510(k)
Active
510(k) K823584
Overview
The Fukuda Denshi 6-Channel Auto. Electrocardiograph is a medical device classified as an electrocardiograph, designed to record the electrical activity of the heart. It provides simultaneous tracing of six leads, enabling comprehensive cardiac monitoring for diagnostic purposes. This device is intended for use in clinical settings to assess heart rhythm, detect abnormalities, and support cardiovascular evaluations. Its automated features enhance ease of use for healthcare professionals.
This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K823584) with a classification under regulation 870.2340. It is intended for use in cardiovascular settings and requires proper maintenance and calibration to ensure accurate readings. The device is not indicated for single-use applications and must be stored in accordance with manufacturer guidelines to preserve functionality and sterility. No additional regulatory status beyond the stated 510(k) clearance is implied.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823584 | Date30 Dec 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DPS
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Brentwood Instruments, Inc.
Questions
What is the Fukuda Denshi 6-Channel Auto. Electrocardiograph used for?
This device is designed to record the electrical activity of the heart by simultaneously tracing six leads. It is primarily used in clinical settings to assess heart rhythm, detect cardiac abnormalities, and support comprehensive cardiovascular evaluations. The automated features simplify operation for healthcare professionals, making it ideal for diagnostic purposes.
Is the Fukuda Denshi 6-Channel Auto. Electrocardiograph reusable or single-use?
The device is explicitly supplied as a reusable medical instrument. It is not intended for single-use applications and requires proper maintenance, calibration, and cleaning to ensure accurate readings and longevity. Reusability aligns with its design for clinical environments where durability and repeated use are essential.
What regulatory clearance does this electrocardiograph hold?
The Fukuda Denshi 6-Channel Auto. Electrocardiograph holds FDA 510(k) clearance under the reference number K823584. This clearance confirms that the device meets regulatory standards for safety and effectiveness as a substantially equivalent product to previously approved electrocardiographs. The classification under regulation 870.2340 further supports its use in cardiovascular monitoring.
How should this device be stored to maintain functionality and sterility?
To preserve functionality and sterility, this device must be stored according to the manufacturer’s guidelines. Since it is reusable, storage should follow protocols that prevent contamination and ensure proper maintenance. This typically includes keeping the device in a clean, dry environment, away from direct sunlight or extreme temperatures, and using protective covers or cases when not in use.
What maintenance is required to ensure accurate readings?
Regular maintenance and calibration are critical to ensure the accuracy and reliability of this electrocardiograph. The device must be serviced by trained personnel following the manufacturer’s instructions, which may include periodic checks of electrodes, leads, and internal components. Proper calibration aligns the device’s output with clinical standards, guaranteeing consistent diagnostic results for healthcare providers.