MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM— 510(k) K033492

Name: FDA 510(k) clearance K033492
Creator: U.S. Food and Drug Administration
Published: 2003-11-24

Substantially Equivalent

Ge Medical Systems Information Technologies

FDA 510(k) clearance K033492 for MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM, Substantially Equivalent on 2003-11-24. Applicant: Ge Medical Systems Information Technologies. Device class: 2.

Clearance details

Applicant: Ge Medical Systems Information Technologies
Product code: Code MHX
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2003-11-04
Decision date: 2003-11-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MHX

view all

K260656 — Carescape ONE +6 more2026-09-01
K260343 — Carescape Canvas 1000; Carescape Canvas Smart Display2026-08-28
K260579 — Infinity® Acute Care System (IACS) VG8.12026-08-20
K251508 — Telemetry Monitor (iT30, iT50)2026-08-06
K253277 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P2026-07-24

More clearances from Ge Medical Systems Information Technologies

view all

K120770 — QT GUARD PLUS ANALYSIS SYSTEM2012-12-06
K102426 — CARESCAPE MODEL V100 VITAL SIGNS MONITOR2010-10-20
K092369 — 12SL ECG ANALYSIS PROGRAM2010-02-24
K093141 — MARS HOLTER ANALYSIS WORKSTATION2009-12-29
K092027 — CARESCAPE MONITOR B8502009-08-28

Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.