FUTUREMED ECG SYSTEM 500— 510(k) K862381

Substantially Equivalent

Futuremed Div. of Future Impex Corp.

FDA 510(k) clearance K862381 for FUTUREMED ECG SYSTEM 500, Substantially Equivalent on 1986-07-17. Applicant: Futuremed Div. of Future Impex Corp..

Clearance details

Applicant: Futuremed Div. of Future Impex Corp.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1986-06-24
Decision date: 1986-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerpark, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.