FDA 510(k)

필터 및 HME/필터

K-번호: K221472 · 2023-02-08

신청자Ningbo Huakun Medical Equipment Co., Ltd.

결정일2023-02-08

제품 코드CAH

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

결정대체적으로 동일

기기 요약

Filter and HME/Filter is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Huakun Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2023-02-08 under 510(k) number K221472. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Filter and HME/Filter?

Filter and HME/Filter is a medical device that received FDA 510(k) clearance on 2023-02-08. The listed applicant is Ningbo Huakun Medical Equipment Co., Ltd.. The 510(k) number is K221472.

When did Filter and HME/Filter receive FDA 510(k) clearance?

Filter and HME/Filter received FDA 510(k) clearance on 2023-02-08, under 510(k) number K221472.

Who is the listed applicant for Filter and HME/Filter?

The FDA 510(k) record lists Ningbo Huakun Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Filter and HME/Filter?

The FDA product code for Filter and HME/Filter is CAH.

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

필터 및 HME/필터

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: CAH)

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