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FDA 510(k)

AURIS AEP

K-Number: K012415 · 2001-12-18

ApplicantSynapsys, Inc.
Decision Date2001-12-18
Product CodeGWJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AURIS AEP is the device name listed in this FDA 510(k) record. The listed applicant is Synapsys, Inc.. It received FDA 510(k) clearance on 2001-12-18 under 510(k) number K012415. 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 AURIS AEP?

AURIS AEP is a medical device that received FDA 510(k) clearance on 2001-12-18. The listed applicant is Synapsys, Inc.. The 510(k) number is K012415.

When did AURIS AEP receive FDA 510(k) clearance?

AURIS AEP received FDA 510(k) clearance on 2001-12-18, under 510(k) number K012415.

Who is the listed applicant for AURIS AEP?

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

What is the FDA product code for AURIS AEP?

The FDA product code for AURIS AEP is GWJ.

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Other records listing Synapsys, Inc. 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.

K982103ULMER (VNG) VIDEO NYSTAGMOGRAPH

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 GmbHK193033GSI Audera ProGrason StadlerK163326SmartEPIntelligent Hearing Systems

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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