CALG-STR EXERCISE ECG ANALYSIS ALGORITHM— 510(k) K112959

Name: FDA 510(k) clearance K112959
Creator: U.S. Food and Drug Administration
Published: 2012-01-26

Substantially Equivalent

Philips Health Care

FDA 510(k) clearance K112959 for CALG-STR EXERCISE ECG ANALYSIS ALGORITHM, Substantially Equivalent on 2012-01-26. Applicant: Philips Health Care. Device class: 2.

Clearance details

Applicant: Philips Health Care
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 2011-10-04
Decision date: 2012-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thousand Oaks, CA, US

Download summary PDF View on FDA.gov ↗

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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.