PHILIPS ECG LEADWIRE SET— 510(k) K110287

Substantially Equivalent

Philips Medical Systems

FDA 510(k) clearance K110287 for PHILIPS ECG LEADWIRE SET, Substantially Equivalent on 2011-02-15. Applicant: Philips Medical Systems.

Clearance details

Applicant: Philips Medical Systems
Product code: Code DSA
Advisory panel: Cardiovascular
Date received: 2011-01-31
Decision date: 2011-02-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

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.