MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR— 510(k) K970763

Substantially Equivalent

Medical Data Electronics

FDA 510(k) clearance K970763 for MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR, Substantially Equivalent on 1997-07-14. Applicant: Medical Data Electronics.

Clearance details

Applicant: Medical Data Electronics
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 1997-03-03
Decision date: 1997-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arleta, CA, US

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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.