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FDA 510(k)

SMK, CX, CXE, RCN

K-Number: K042375 · 2004-10-26

ApplicantTechnomed Europe
Decision Date2004-10-26
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SMK, CX, CXE, RCN is the device name listed in this FDA 510(k) record. The listed applicant is Technomed Europe. It received FDA 510(k) clearance on 2004-10-26 under 510(k) number K042375. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMK, CX, CXE, RCN?

SMK, CX, CXE, RCN is a medical device that received FDA 510(k) clearance on 2004-10-26. The listed applicant is Technomed Europe. The 510(k) number is K042375.

When did SMK, CX, CXE, RCN receive FDA 510(k) clearance?

SMK, CX, CXE, RCN received FDA 510(k) clearance on 2004-10-26, under 510(k) number K042375.

Who is the listed applicant for SMK, CX, CXE, RCN?

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

What is the FDA product code for SMK, CX, CXE, RCN?

The FDA product code for SMK, CX, CXE, RCN is GXI.

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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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