ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION— 510(k) K914458

Substantially Equivalent

Medical Data Electronics

FDA 510(k) clearance K914458 for ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION, Substantially Equivalent on 1991-12-09. Applicant: Medical Data Electronics.

Clearance details

Applicant: Medical Data Electronics
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1991-10-07
Decision date: 1991-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arleta, CA, US

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Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.