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FDA 510(k)

NeuroEars-Anna™

K-Number: K243709 · 2025-08-25

ApplicantNeuroears, Inc.
Decision Date2025-08-25
Product CodeGWN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NeuroEars-Anna™ is the device name listed in this FDA 510(k) record. The listed applicant is Neuroears, Inc.. It received FDA 510(k) clearance on 2025-08-25 under 510(k) number K243709. The device is classified under product code GWN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuroEars-Anna™?

NeuroEars-Anna™ is a medical device that received FDA 510(k) clearance on 2025-08-25. The listed applicant is Neuroears, Inc.. The 510(k) number is K243709.

When did NeuroEars-Anna™ receive FDA 510(k) clearance?

NeuroEars-Anna™ received FDA 510(k) clearance on 2025-08-25, under 510(k) number K243709.

Who is the listed applicant for NeuroEars-Anna™?

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

What is the FDA product code for NeuroEars-Anna™?

The FDA product code for NeuroEars-Anna™ is GWN.

Related Devices (Code: GWN)

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.

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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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