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FDA 510(k)

EKG SPEAKS

K-Number: K032926 · 2003-10-15

ApplicantMedtronic Vascular
Decision Date2003-10-15
Product CodeKRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EKG SPEAKS is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2003-10-15 under 510(k) number K032926. The device is classified under product code KRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EKG SPEAKS?

EKG SPEAKS is a medical device that received FDA 510(k) clearance on 2003-10-15. The listed applicant is Medtronic Vascular. The 510(k) number is K032926.

When did EKG SPEAKS receive FDA 510(k) clearance?

EKG SPEAKS received FDA 510(k) clearance on 2003-10-15, under 510(k) number K032926.

Who is the listed applicant for EKG SPEAKS?

The FDA 510(k) record lists Medtronic Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EKG SPEAKS?

The FDA product code for EKG SPEAKS is KRE.

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Related Devices (Code: KRE)

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.

K110693PACEART OPTIMA SYSTEM SOFTWAREMedtronic, Inc.K072950CYGNUS 12 LEAD ECG MODULECygnus, LLCK922742HPM 40 HEART PACEMAKER MONITORBiotronik, GmbH & Co.K915632PACEART CPTS-86/12Paceart, Inc.K895535PACEVIEWMicromedicalK870909PACEMAKER FUNCTION ANALYZERPaceart, Inc.

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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