FDA 510(k)

FRAXION

K-Number: K112210 · 2011-11-22

ApplicantMedical Intelligence Medizintechnik GmbH

Decision Date2011-11-22

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

FRAXION is the device name listed in this FDA 510(k) record. The listed applicant is Medical Intelligence Medizintechnik GmbH. It received FDA 510(k) clearance on 2011-11-22 under 510(k) number K112210. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRAXION?

FRAXION is a medical device that received FDA 510(k) clearance on 2011-11-22. The listed applicant is Medical Intelligence Medizintechnik GmbH. The 510(k) number is K112210.

When did FRAXION receive FDA 510(k) clearance?

FRAXION received FDA 510(k) clearance on 2011-11-22, under 510(k) number K112210.

Who is the listed applicant for FRAXION?

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

What is the FDA product code for FRAXION?

The FDA product code for FRAXION is IYE.

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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.