FDA 510(k)

Multiflex Tinnitus Technology

Número K: K201370 · 2020-06-19

Data da decisão2020-06-19

Código do produtoKLW

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Multiflex Tinnitus Technology is the device name listed in this FDA 510(k) record. The listed applicant is Starkey Laboratories, Inc.. It received FDA 510(k) clearance on 2020-06-19 under 510(k) number K201370. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Multiflex Tinnitus Technology?

Multiflex Tinnitus Technology is a medical device that received FDA 510(k) clearance on 2020-06-19. The listed applicant is Starkey Laboratories, Inc.. The 510(k) number is K201370.

When did Multiflex Tinnitus Technology receive FDA 510(k) clearance?

Multiflex Tinnitus Technology received FDA 510(k) clearance on 2020-06-19, under 510(k) number K201370.

Who is the listed applicant for Multiflex Tinnitus Technology?

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

What is the FDA product code for Multiflex Tinnitus Technology?

The FDA product code for Multiflex Tinnitus Technology is KLW.

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