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FDA 510(k)

DIASYS INTEGRA II

K-Number: K042109 · 2005-03-09

ApplicantNovacor France
Decision Date2005-03-09
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIASYS INTEGRA II is the device name listed in this FDA 510(k) record. The listed applicant is Novacor France. It received FDA 510(k) clearance on 2005-03-09 under 510(k) number K042109. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIASYS INTEGRA II?

DIASYS INTEGRA II is a medical device that received FDA 510(k) clearance on 2005-03-09. The listed applicant is Novacor France. The 510(k) number is K042109.

When did DIASYS INTEGRA II receive FDA 510(k) clearance?

DIASYS INTEGRA II received FDA 510(k) clearance on 2005-03-09, under 510(k) number K042109.

Who is the listed applicant for DIASYS INTEGRA II?

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

What is the FDA product code for DIASYS INTEGRA II?

The FDA product code for DIASYS INTEGRA II is DXN.

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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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