PHILIPS DXL 12/16-LEAD ECG ALGORITHM— 510(k) K132068

Substantially Equivalent

Philips Medical Systems

FDA 510(k) clearance K132068 for PHILIPS DXL 12/16-LEAD ECG ALGORITHM, Substantially Equivalent on 2013-09-26. Applicant: Philips Medical Systems.

Clearance details

Applicant: Philips Medical Systems
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2013-07-03
Decision date: 2013-09-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.