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FDA 510(k)

T-WAVE ALTERNANS (TWA) ALGORITHM OPTION

K-Number: K032513 · 2003-10-30

ApplicantGe Medical Systems Information Technologies
Decision Date2003-10-30
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

T-WAVE ALTERNANS (TWA) ALGORITHM OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies. It received FDA 510(k) clearance on 2003-10-30 under 510(k) number K032513. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T-WAVE ALTERNANS (TWA) ALGORITHM OPTION?

T-WAVE ALTERNANS (TWA) ALGORITHM OPTION is a medical device that received FDA 510(k) clearance on 2003-10-30. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K032513.

When did T-WAVE ALTERNANS (TWA) ALGORITHM OPTION receive FDA 510(k) clearance?

T-WAVE ALTERNANS (TWA) ALGORITHM OPTION received FDA 510(k) clearance on 2003-10-30, under 510(k) number K032513.

Who is the listed applicant for T-WAVE ALTERNANS (TWA) ALGORITHM OPTION?

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

What is the FDA product code for T-WAVE ALTERNANS (TWA) ALGORITHM OPTION?

The FDA product code for T-WAVE ALTERNANS (TWA) ALGORITHM OPTION is DQK.

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Other records listing Ge Medical Systems Information Technologies as applicant

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Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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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