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FDA 510(k)

CARDIOSOFT/CASE CARDIAC TESTING SYSTEM

K-Number: K031561 · 2003-08-01

ApplicantGe Medical Systems Information Technologies
Decision Date2003-08-01
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOSOFT/CASE CARDIAC TESTING SYSTEM 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 2003-08-01 under 510(k) number K031561. 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 CARDIOSOFT/CASE CARDIAC TESTING SYSTEM?

CARDIOSOFT/CASE CARDIAC TESTING SYSTEM is a medical device that received FDA 510(k) clearance on 2003-08-01. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K031561.

When did CARDIOSOFT/CASE CARDIAC TESTING SYSTEM receive FDA 510(k) clearance?

CARDIOSOFT/CASE CARDIAC TESTING SYSTEM received FDA 510(k) clearance on 2003-08-01, under 510(k) number K031561.

Who is the listed applicant for CARDIOSOFT/CASE CARDIAC TESTING SYSTEM?

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 CARDIOSOFT/CASE CARDIAC TESTING SYSTEM?

The FDA product code for CARDIOSOFT/CASE CARDIAC TESTING SYSTEM is DQK.

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Other records listing Ge Medical Systems Information Technologies as applicant

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Related Devices (Code: 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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