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FDA 510(k)

MUSE Cardiology Information System

K-Number: K152993 · 2016-01-12

ApplicantGe Medical Systems Information Technologies, Inc.
Decision Date2016-01-12
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MUSE Cardiology Information 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 2016-01-12 under 510(k) number K152993. 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 MUSE Cardiology Information System?

MUSE Cardiology Information System is a medical device that received FDA 510(k) clearance on 2016-01-12. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K152993.

When did MUSE Cardiology Information System receive FDA 510(k) clearance?

MUSE Cardiology Information System received FDA 510(k) clearance on 2016-01-12, under 510(k) number K152993.

Who is the listed applicant for MUSE Cardiology Information 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 MUSE Cardiology Information System?

The FDA product code for MUSE Cardiology Information System 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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