K821384

Substantially Equivalent

EXERCISE ECG ELECTRODES, REUSABLE

Applicant: Respironics, Inc.
Product code: DRG
Advisory panel: Cardiovascular
Date received: 1982-05-10
Decision date: 1982-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monroeville, PA, US

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.