ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)— 510(k) K073372

Name: FDA 510(k) clearance K073372
Creator: U.S. Food and Drug Administration
Published: 2007-12-07

Substantially Equivalent

Systemsone

FDA 510(k) clearance K073372 for ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI), Substantially Equivalent on 2007-12-07. Applicant: Systemsone. Device class: 2.

Clearance details

Applicant: Systemsone
Product code: Code DXJ
Device class: Class 2
Regulation: 21 CFR 870.2450
Advisory panel: Cardiovascular
Date received: 2007-12-03
Decision date: 2007-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anchorage, AK, US

Download summary PDF View on FDA.gov ↗

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K173107 — Vios Central Station Monitor Software, Vios Central Server Software2018-07-26
K180534 — Philips IntelliVue GuardianSoftware2018-07-16

Adverse events under product code DXJ

product code DXJ

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.