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FDA 510(k)

ELEXOMA MEDIC

K-Number: K070412 · 2008-05-21

ApplicantRedplane AG
Decision Date2008-05-21
Product CodeQJQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELEXOMA MEDIC is the device name listed in this FDA 510(k) record. The listed applicant is Redplane AG. It received FDA 510(k) clearance on 2008-05-21 under 510(k) number K070412. The device is classified under product code QJQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELEXOMA MEDIC?

ELEXOMA MEDIC is a medical device that received FDA 510(k) clearance on 2008-05-21. The listed applicant is Redplane AG. The 510(k) number is K070412.

When did ELEXOMA MEDIC receive FDA 510(k) clearance?

ELEXOMA MEDIC received FDA 510(k) clearance on 2008-05-21, under 510(k) number K070412.

Who is the listed applicant for ELEXOMA MEDIC?

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

What is the FDA product code for ELEXOMA MEDIC?

The FDA product code for ELEXOMA MEDIC is QJQ.

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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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