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FDA 510(k)

DASH 3000/4000 PATIENT MONITOR

K-Number: K001359 · 2000-07-18

ApplicantGeneral Electric Medical Systems Information Techn
Decision Date2000-07-18
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DASH 3000/4000 PATIENT MONITOR 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 2000-07-18 under 510(k) number K001359. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DASH 3000/4000 PATIENT MONITOR?

DASH 3000/4000 PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 2000-07-18. The listed applicant is General Electric Medical Systems Information Techn. The 510(k) number is K001359.

When did DASH 3000/4000 PATIENT MONITOR receive FDA 510(k) clearance?

DASH 3000/4000 PATIENT MONITOR received FDA 510(k) clearance on 2000-07-18, under 510(k) number K001359.

Who is the listed applicant for DASH 3000/4000 PATIENT MONITOR?

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 DASH 3000/4000 PATIENT MONITOR?

The FDA product code for DASH 3000/4000 PATIENT MONITOR is DSI.

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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.

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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: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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