GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC— 510(k) K001112

Clearance details

Applicant

General Electric Medical Systems Information Techn

Product code

Code DXJ

Device class

Class 2

Regulation

21 CFR 870.2450

Advisory panel

Cardiovascular

Date received

2000-04-06

Decision date

2000-06-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Milwaukee, WI, US

• K212003 — ESSENZ Patient Monitor2021-11-10
• K212208 — Philips IntelliVue GuardianSoftware (Rev. E.0X)2021-09-30
• K201162 — Essence 55SP Large Monitor System2020-08-27
• K173107 — Vios Central Station Monitor Software, Vios Central Server Software2018-07-26
• K180534 — Philips IntelliVue GuardianSoftware2018-07-16

• K023380 — T-WAVE ALTERMANS (TWA) ALGORITHM OPTION2002-12-03
• K021470 — SEER LIGHT COMPACT DIGITAL HOLTER RECORDER2002-11-14
• K023100 — ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS2002-10-11
• K021454 — UNITY NETWORK ID2002-10-01
• K020290 — DASH 3000/4000 PATIENT MONITOR2002-08-14

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 →