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FDA 510(k)

GSI Audera Pro

K-Number: K193033 · 2020-04-24

ApplicantGrason Stadler
Decision Date2020-04-24
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GSI Audera Pro is a medical device manufactured by Grason Stadler. It received FDA 510(k) clearance on 2020-04-24 under approval number K193033. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GSI Audera Pro?

GSI Audera Pro is a medical device that received FDA 510(k) clearance on 2020-04-24. It is manufactured by Grason Stadler. The 510(k) number is K193033.

When was GSI Audera Pro approved by the FDA?

GSI Audera Pro received FDA 510(k) clearance on 2020-04-24, under approval number K193033.

What company makes GSI Audera Pro?

GSI Audera Pro is manufactured by Grason Stadler.

What is the FDA product code for GSI Audera Pro?

The FDA product code for GSI Audera Pro is GWJ.

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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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