FDA 510(k)

Nuheara IQbuds 2 PRO Hearing Aid

K-번호: K221064 · 2022-10-30

결정일2022-10-30

제품 코드QUH

자문 위원회EN

결정Substantially Equivalent

기기 요약

Nuheara IQbuds 2 PRO Hearing Aid is the device name listed in this FDA 510(k) record. The listed applicant is Nuheara Limited. It received FDA 510(k) clearance on 2022-10-30 under 510(k) number K221064. The device is classified under product code QUH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Nuheara IQbuds 2 PRO Hearing Aid?

Nuheara IQbuds 2 PRO Hearing Aid is a medical device that received FDA 510(k) clearance on 2022-10-30. The listed applicant is Nuheara Limited. The 510(k) number is K221064.

When did Nuheara IQbuds 2 PRO Hearing Aid receive FDA 510(k) clearance?

Nuheara IQbuds 2 PRO Hearing Aid received FDA 510(k) clearance on 2022-10-30, under 510(k) number K221064.

Who is the listed applicant for Nuheara IQbuds 2 PRO Hearing Aid?

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

What is the FDA product code for Nuheara IQbuds 2 PRO Hearing Aid?

The FDA product code for Nuheara IQbuds 2 PRO Hearing Aid is QUH.

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

Nuheara IQbuds 2 PRO Hearing Aid

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: QUH)

공식 출처