MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500— 510(k) K012336

Substantially Equivalent

Medical Data Electronics

FDA 510(k) clearance K012336 for MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500, Substantially Equivalent on 2001-10-03. Applicant: Medical Data Electronics.

Clearance details

Applicant: Medical Data Electronics
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 2001-07-24
Decision date: 2001-10-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Arleta, CA, US

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Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.