FDA 510(k)

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System

K-Nummer: K231870 · 2023-12-13

AntragstellerGe Medical Systems Information Technologies, Inc.

Entscheidungsdatum2023-12-13

ProduktcodeDQK

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2023-12-13 under 510(k) number K231870. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System?

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System is a medical device that received FDA 510(k) clearance on 2023-12-13. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K231870.

When did CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System receive FDA 510(k) clearance?

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System received FDA 510(k) clearance on 2023-12-13, under 510(k) number K231870.

Who is the listed applicant for CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System?

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

What is the FDA product code for CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System?

The FDA product code for CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System is DQK.

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