PATIENTNET MONITORING SYSTEM— 510(k) K020524

Name: FDA 510(k) clearance K020524
Creator: U.S. Food and Drug Administration
Published: 2002-03-20

Substantially Equivalent

General Electric Medical Systems Information Techn

FDA 510(k) clearance K020524 for PATIENTNET MONITORING SYSTEM, Substantially Equivalent on 2002-03-20. Applicant: General Electric Medical Systems Information Techn. Device class: 2.

Clearance details

Applicant: General Electric Medical Systems Information Techn
Product code: Product code MSX
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2002-02-19
Decision date: 2002-03-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Tustin, CA, US

Download summary PDF View on FDA.gov ↗

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K020290 — DASH 3000/4000 PATIENT MONITOR2002-08-14

Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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.