ANALYZER, PACER SYSTEM, PSA-5— 510(k) K781144

Substantially Equivalent

Edwards Pacemaker Systems

FDA 510(k) clearance K781144 for ANALYZER, PACER SYSTEM, PSA-5, Substantially Equivalent on 1978-08-23. Applicant: Edwards Pacemaker Systems.

Clearance details

Applicant: Edwards Pacemaker Systems
Product code: Code DTC
Advisory panel: Cardiovascular
Date received: 1978-07-10
Decision date: 1978-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTC

product code DTC

Injury: 136
Malfunction: 3,400
Total: 3,536

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.