FDA 510(k)

Examion X-AQS

K-Number: K170729 · 2017-07-18

Decision Date2017-07-18

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Examion X-AQS is the device name listed in this FDA 510(k) record. The listed applicant is Examion GmbH. It received FDA 510(k) clearance on 2017-07-18 under 510(k) number K170729. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Examion X-AQS?

Examion X-AQS is a medical device that received FDA 510(k) clearance on 2017-07-18. The listed applicant is Examion GmbH. The 510(k) number is K170729.

When did Examion X-AQS receive FDA 510(k) clearance?

Examion X-AQS received FDA 510(k) clearance on 2017-07-18, under 510(k) number K170729.

Who is the listed applicant for Examion X-AQS?

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

What is the FDA product code for Examion X-AQS?

The FDA product code for Examion X-AQS is LLZ.

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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.