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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 the device name listed in this FDA 510(k) record. The listed applicant is Grason Stadler. It received FDA 510(k) clearance on 2020-04-24 under 510(k) 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. The listed applicant is Grason Stadler. The 510(k) number is K193033.

When did GSI Audera Pro receive FDA 510(k) clearance?

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

Who is the listed applicant for GSI Audera Pro?

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

What is the FDA product code for GSI Audera Pro?

The FDA product code for GSI Audera Pro is GWJ.

Other records listing Grason Stadler as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180287GSI CortiK172403GSI Novus

Related Devices (Code: GWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc.K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K220139QScreenPath Medical GmbHK211147ALGO 7iPath Medical GmbHK163326SmartEPIntelligent Hearing SystemsK162037Eclipse with VEMPInteracoustics A/S

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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