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FDA 510(k)

R-TEST EVOLUTION 3

K-Number: K040753 · 2004-06-10

ApplicantNovacor
Decision Date2004-06-10
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

R-TEST EVOLUTION 3 is the device name listed in this FDA 510(k) record. The listed applicant is Novacor. It received FDA 510(k) clearance on 2004-06-10 under 510(k) number K040753. The device is classified under product code MLO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R-TEST EVOLUTION 3?

R-TEST EVOLUTION 3 is a medical device that received FDA 510(k) clearance on 2004-06-10. The listed applicant is Novacor. The 510(k) number is K040753.

When did R-TEST EVOLUTION 3 receive FDA 510(k) clearance?

R-TEST EVOLUTION 3 received FDA 510(k) clearance on 2004-06-10, under 510(k) number K040753.

Who is the listed applicant for R-TEST EVOLUTION 3?

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

What is the FDA product code for R-TEST EVOLUTION 3?

The FDA product code for R-TEST EVOLUTION 3 is MLO.

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Other records listing Novacor 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.

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Related Devices (Code: MLO)

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.

K261580ZBPro Diagnostic (Version 2.0)Zbeats, Inc.K241890Philips Holter Analysis SystemPhilips Medizin Systeme Böblingen GmbHK240794Frontier X PlusFourth Frontier Technologies Pvt, Ltd.K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.K193177CER-SCardiocalmK182030Faros MobileBittium Biosignals , Ltd.

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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