FDA 510(k)

Acapella Choice Blue Vibratory PEP Device

K-번호: K181660 · 2019-10-24

결정일2019-10-24

제품 코드BWF

자문 위원회안내: 의료기기 규제 문서 번역 요청입니다. 회사명, 제품명, FDA, 510(k), PMA, NCT, PMID, 식별자 및 URL을 보존하여 번역하여 주세요. 정책: 의료규제-v1. [원문] AN [번역] 안내

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기기 요약

Acapella Choice Blue Vibratory PEP Device is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical. It received FDA 510(k) clearance on 2019-10-24 under 510(k) number K181660. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Acapella Choice Blue Vibratory PEP Device?

Acapella Choice Blue Vibratory PEP Device is a medical device that received FDA 510(k) clearance on 2019-10-24. The listed applicant is Smiths Medical. The 510(k) number is K181660.

When did Acapella Choice Blue Vibratory PEP Device receive FDA 510(k) clearance?

Acapella Choice Blue Vibratory PEP Device received FDA 510(k) clearance on 2019-10-24, under 510(k) number K181660.

Who is the listed applicant for Acapella Choice Blue Vibratory PEP Device?

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

What is the FDA product code for Acapella Choice Blue Vibratory PEP Device?

The FDA product code for Acapella Choice Blue Vibratory PEP Device is BWF.

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Acapella Choice Blue Vibratory PEP Device

기기 요약

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관련 임상시험

관련 기기 (코드: BWF)

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