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FDA 510(k)

R.TEST EVOLUTION

K-Number: K993788 · 2000-08-04

ApplicantNovacor Div.
Decision Date2000-08-04
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

R.TEST EVOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Novacor Div.. It received FDA 510(k) clearance on 2000-08-04 under 510(k) number K993788. 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?

R.TEST EVOLUTION is a medical device that received FDA 510(k) clearance on 2000-08-04. The listed applicant is Novacor Div.. The 510(k) number is K993788.

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

R.TEST EVOLUTION received FDA 510(k) clearance on 2000-08-04, under 510(k) number K993788.

Who is the listed applicant for R.TEST EVOLUTION?

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

What is the FDA product code for R.TEST EVOLUTION?

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

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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.

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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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