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FDA 510(k)

MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE

K-Number: K083639 · 2009-02-17

ApplicantGe Medical Systems Information Technologies
Decision Date2009-02-17
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE 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 2009-02-17 under 510(k) number K083639. 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 WITH VMWARE?

MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE is a medical device that received FDA 510(k) clearance on 2009-02-17. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K083639.

When did MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE receive FDA 510(k) clearance?

MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE received FDA 510(k) clearance on 2009-02-17, under 510(k) number K083639.

Who is the listed applicant for MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE?

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 MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE?

The FDA product code for MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE is DQK.

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Other records listing Ge Medical Systems Information Technologies as applicant

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K120770QT GUARD PLUS ANALYSIS SYSTEMK102426CARESCAPE MODEL V100 VITAL SIGNS MONITORK09236912SL ECG ANALYSIS PROGRAMK093141MARS HOLTER ANALYSIS WORKSTATIONK092027CARESCAPE MONITOR B850K090702MODIFICATION TO DASH 2500 PATIENT MONITOR

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Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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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