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FDA 510(k)

Wireless Audio System

K-Number: K173409 · 2018-02-16

ApplicantNeocoil, LLC
Decision Date2018-02-16
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Wireless Audio System is the device name listed in this FDA 510(k) record. The listed applicant is Neocoil, LLC. It received FDA 510(k) clearance on 2018-02-16 under 510(k) number K173409. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wireless Audio System?

Wireless Audio System is a medical device that received FDA 510(k) clearance on 2018-02-16. The listed applicant is Neocoil, LLC. The 510(k) number is K173409.

When did Wireless Audio System receive FDA 510(k) clearance?

Wireless Audio System received FDA 510(k) clearance on 2018-02-16, under 510(k) number K173409.

Who is the listed applicant for Wireless Audio System?

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

What is the FDA product code for Wireless Audio System?

The FDA product code for Wireless Audio System is LNH.

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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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