ESCORT ECG MONITOR SIEMENS SIRECUST 466— 510(k) K854234

Substantially Equivalent

Medical Data Electronics

FDA 510(k) clearance K854234 for ESCORT ECG MONITOR SIEMENS SIRECUST 466, Substantially Equivalent on 1986-01-21. Applicant: Medical Data Electronics.

Clearance details

Applicant: Medical Data Electronics
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1985-10-21
Decision date: 1986-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arleta, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.