Futuremed ECG System 500
by Futuremed Div. of Future Impex Corp. 510(k)
Active
510(k) K862381
Overview
The Futuremed ECG System 500 is an electrocardiogram (ECG) device designed for recording and analyzing the electrical activity of the heart. It falls under the classification of a diagnostic electrocardiograph, enabling healthcare professionals to assess cardiac function and diagnose potential arrhythmias or other cardiac conditions.
This device is intended for use in clinical settings, including hospitals and cardiac care units, and has received FDA 510(k) clearance under the product code DPS. The system was reviewed by the Cardiovascular (CV) Advisory Committee and is classified as substantially equivalent to a predicate device. It was cleared in 1986 under K-number K862381.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK862381 | Date17 Jul 1986 | 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- Withdrawn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