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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 a medical device manufactured by Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2016-01-12 under approval 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. It is manufactured by Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K152993.

When was MUSE Cardiology Information System approved by the FDA?

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

What company makes MUSE Cardiology Information System?

MUSE Cardiology Information System is manufactured by Ge Medical Systems Information Technologies, Inc..

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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Related PubMed Literature

PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025) PMID: 31472187 A translational framework for peripheral nerve stimulating electrodes: Reviewing the journey from concept to clinic. Journal of neuroscience methods (2019) PMID: 25262248 Unique device identifiers for coronary stent postmarket surveillance and research: a report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier demonstration. American heart journal (2014)

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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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