K992524

Substantially Equivalent

PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES

Applicant: Advantage Medical Electronics, Inc.
Product code: DSA
Advisory panel: Cardiovascular
Date received: 1999-07-28
Decision date: 2000-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coral Springs, FL, US

Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.