ST80I STRESS TEST SYSTEM— 510(k) K121638

Substantially Equivalent

Philips Health Care

FDA 510(k) clearance K121638 for ST80I STRESS TEST SYSTEM, Substantially Equivalent on 2012-07-18. Applicant: Philips Health Care.

Clearance details

Applicant: Philips Health Care
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2012-06-04
Decision date: 2012-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Thousand Oaks, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.