FDA 510(k)

Tinnitogram Signal Generator

K-번호: K221168 · 2023-02-01

결정일2023-02-01

제품 코드KLW

자문 위원회EN

결정Substantially Equivalent

기기 요약

Tinnitogram Signal Generator is the device name listed in this FDA 510(k) record. The listed applicant is Goldenear Company, Inc.. It received FDA 510(k) clearance on 2023-02-01 under 510(k) number K221168. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Tinnitogram Signal Generator?

Tinnitogram Signal Generator is a medical device that received FDA 510(k) clearance on 2023-02-01. The listed applicant is Goldenear Company, Inc.. The 510(k) number is K221168.

When did Tinnitogram Signal Generator receive FDA 510(k) clearance?

Tinnitogram Signal Generator received FDA 510(k) clearance on 2023-02-01, under 510(k) number K221168.

Who is the listed applicant for Tinnitogram Signal Generator?

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

What is the FDA product code for Tinnitogram Signal Generator?

The FDA product code for Tinnitogram Signal Generator is KLW.

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Tinnitogram Signal Generator

기기 요약

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관련 임상시험

관련 기기 (코드: KLW)

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