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FDA 510(k)

T-WAVE ALTERMANS (TWA) ALGORITHM OPTION

K-Number: K023380 · 2002-12-03

ApplicantGeneral Electric Medical Systems Information Techn
Decision Date2002-12-03
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

T-WAVE ALTERMANS (TWA) ALGORITHM OPTION 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 2002-12-03 under 510(k) number K023380. 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 ALTERMANS (TWA) ALGORITHM OPTION?

T-WAVE ALTERMANS (TWA) ALGORITHM OPTION is a medical device that received FDA 510(k) clearance on 2002-12-03. The listed applicant is General Electric Medical Systems Information Techn. The 510(k) number is K023380.

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

T-WAVE ALTERMANS (TWA) ALGORITHM OPTION received FDA 510(k) clearance on 2002-12-03, under 510(k) number K023380.

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

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 T-WAVE ALTERMANS (TWA) ALGORITHM OPTION?

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

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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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