PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A— 510(k) K032103

Substantially Equivalent

Philips Medical Systems

FDA 510(k) clearance K032103 for PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A, Substantially Equivalent on 2003-07-22. Applicant: Philips Medical Systems.

Clearance details

Applicant: Philips Medical Systems
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 2003-07-08
Decision date: 2003-07-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

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.