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FDA 510(k)

GE MARQUETTE ECG ANALYSIS PROGRAM

K-Number: K002209 · 2000-08-18

ApplicantGeneral Electric Medical Systems Information Techn
Decision Date2000-08-18
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GE MARQUETTE ECG ANALYSIS PROGRAM is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Medical Systems Information Techn. It received FDA 510(k) clearance on 2000-08-18 under 510(k) number K002209. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE MARQUETTE ECG ANALYSIS PROGRAM?

GE MARQUETTE ECG ANALYSIS PROGRAM is a medical device that received FDA 510(k) clearance on 2000-08-18. The listed applicant is General Electric Medical Systems Information Techn. The 510(k) number is K002209.

When did GE MARQUETTE ECG ANALYSIS PROGRAM receive FDA 510(k) clearance?

GE MARQUETTE ECG ANALYSIS PROGRAM received FDA 510(k) clearance on 2000-08-18, under 510(k) number K002209.

Who is the listed applicant for GE MARQUETTE ECG ANALYSIS PROGRAM?

The FDA 510(k) record lists General Electric Medical Systems Information Techn as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GE MARQUETTE ECG ANALYSIS PROGRAM?

The FDA product code for GE MARQUETTE ECG ANALYSIS PROGRAM is MHX.

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Other records listing General Electric Medical Systems Information Techn as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K023380T-WAVE ALTERMANS (TWA) ALGORITHM OPTIONK021470SEER LIGHT COMPACT DIGITAL HOLTER RECORDERK023100ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTSK021454UNITY NETWORK IDK020290DASH 3000/4000 PATIENT MONITORK021366MAC-LAB/CARDIOLAB EP/COMBOLAB

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Related Devices (Code: MHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0MGE Healthcare Finland OyK260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland OyK260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc.K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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