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FDA 510(k)

IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM

K-Number: K994430 · 2000-03-28

ApplicantGeneral Electric Medical Systems Information Techn
Decision Date2000-03-28
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM 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 2000-03-28 under 510(k) number K994430. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM?

IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM is a medical device that received FDA 510(k) clearance on 2000-03-28. The listed applicant is General Electric Medical Systems Information Techn. The 510(k) number is K994430.

When did IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM receive FDA 510(k) clearance?

IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM received FDA 510(k) clearance on 2000-03-28, under 510(k) number K994430.

Who is the listed applicant for IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM?

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 IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM?

The FDA product code for IMPACT.WF MOBILE WAVEFORM RECEIVING SYSTEM is MSX.

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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: MSX)

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.

K261287Digistat CareAscom Ums Srl UnipersonaleK260211Dashboard (P007000)Hill-Rom, Inc.K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbHK243270TigerConnect Alarm ManagementTigerconnectK242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.

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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