MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414— 510(k) K014294

Substantially Equivalent

Medical Data Electronics

FDA 510(k) clearance K014294 for MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414, Substantially Equivalent on 2002-01-25. Applicant: Medical Data Electronics.

Clearance details

Applicant: Medical Data Electronics
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2001-12-28
Decision date: 2002-01-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Arleta, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.