PERSONAL CL SINGLE-CHANNEL ELECTROCAR— 510(k) K842123

Substantially Equivalent

Parexel Intl. Corp.

FDA 510(k) clearance K842123 for PERSONAL CL SINGLE-CHANNEL ELECTROCAR, Substantially Equivalent on 1984-11-16. Applicant: Parexel Intl. Corp..

Clearance details

Applicant: Parexel Intl. Corp.
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 1984-05-29
Decision date: 1984-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.