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FDA 510(k)

HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES

K-Number: K042148 · 2004-12-03

ApplicantGe Medical Syst. Information Technologies
Decision Date2004-12-03
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Syst. Information Technologies. It received FDA 510(k) clearance on 2004-12-03 under 510(k) number K042148. 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 HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES?

HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES is a medical device that received FDA 510(k) clearance on 2004-12-03. The listed applicant is Ge Medical Syst. Information Technologies. The 510(k) number is K042148.

When did HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES receive FDA 510(k) clearance?

HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES received FDA 510(k) clearance on 2004-12-03, under 510(k) number K042148.

Who is the listed applicant for HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES?

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

What is the FDA product code for HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES?

The FDA product code for HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES is DQK.

Related Clinical Trials

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.

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Other records listing Ge Medical Syst. Information Technologies as applicant

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.

K090212MAC 800 RESTING ECG ANALYSIS SYSTEM

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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