ESCORT 100/300 SERIES B PATIENT MONITORS— 510(k) K930004

Substantially Equivalent

Medical Data Electronics

FDA 510(k) clearance K930004 for ESCORT 100/300 SERIES B PATIENT MONITORS, Substantially Equivalent on 1993-06-23. Applicant: Medical Data Electronics.

Clearance details

Applicant: Medical Data Electronics
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1993-01-04
Decision date: 1993-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arleta, CA, US

Download summary PDF View on FDA.gov ↗

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.