THE BUDDY SYSTEM W/OPTIONAL ECG ELECTRODE— 510(k) K871748

Substantially Equivalent

The Buddy Systems, Inc.

FDA 510(k) clearance K871748 for THE BUDDY SYSTEM W/OPTIONAL ECG ELECTRODE, Substantially Equivalent on 1987-06-10. Applicant: The Buddy Systems, Inc..

Clearance details

Applicant: The Buddy Systems, Inc.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 1987-05-05
Decision date: 1987-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.