Fukuda Denshi Model FCP-220
by Brentwood Instruments, Inc. 510(k)
Active
510(k) K844470
Overview
The Fukuda Denshi Model FCP-220 is a cardiovascular electrocardiogram (ECG) device, designed for recording electrical activity of the heart. It falls under the product code DPS and is classified as a Class II medical device. This equipment is intended for diagnostic purposes, enabling healthcare professionals to assess cardiac function through graphical representation of heart rhythms.
The device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K844470), granted in 1985. It is intended for use in clinical settings, including hospitals and cardiovascular diagnostic centers. No specific sterility requirements are noted, but standard medical device cleaning and maintenance protocols apply. The device’s regulatory filing was reviewed by the Cardiovascular (CV) Advisory Committee.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK844470 | Date10 Jan 1985 | 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- Withdrawn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 Model FCP-220 used for?
The Fukuda Denshi Model FCP-220 is a cardiovascular electrocardiogram (ECG) device designed to record the electrical activity of the heart. It provides graphical representations of heart rhythms, enabling healthcare professionals to assess cardiac function for diagnostic purposes in clinical settings like hospitals and cardiovascular diagnostic centers.
Is the FCP-220 a reusable or single-use device?
The Fukuda Denshi Model FCP-220 is supplied as a reusable medical instrument. As with all reusable devices, it must be cleaned and maintained according to standard medical device protocols to ensure proper functionality and patient safety.
What regulatory approval does the FCP-220 hold?
The FCP-220 received FDA 510(k) clearance under the reference number K844470, granted in 1985. This clearance was determined through a traditional review process and was classified as substantially equivalent to a predicate device. The device falls under product code DPS and is classified as a Class II medical device.
Are there specific sterility requirements for the FCP-220?
The device description does not specify any unique sterility requirements beyond standard medical device cleaning and maintenance protocols. Reusable devices like the FCP-220 must be thoroughly cleaned and disinfected between uses to prevent cross-contamination and ensure reliable performance.
What advisory committee reviewed the FCP-220’s regulatory filing?
The regulatory filing for the Fukuda Denshi Model FCP-220 was reviewed by the Cardiovascular (CV) Advisory Committee. This committee provides expert advice on cardiovascular devices, ensuring that submissions meet appropriate safety and effectiveness standards before clearance.