K992413

Substantially Equivalent

ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR

Applicant: Medical Data Electronics
Product code: DRT
Advisory panel: Cardiovascular
Date received: 1999-07-20
Decision date: 1999-08-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Arleta, CA, US

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.