K112959

Substantially Equivalent

CALG-STR EXERCISE ECG ANALYSIS ALGORITHM

Applicant: Philips Health Care
Product code: DPS
Advisory panel: Cardiovascular
Date received: 2011-10-04
Decision date: 2012-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thousand Oaks, CA, US

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.