FDA 510(k)

Peak flow meter

K-번호: K203196 · 2021-05-26

신청자Shanghai Sonmol Medical Equipment Co., Ltd.

결정일2021-05-26

제품 코드BZH

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

결정Substantially Equivalent

기기 요약

Peak flow meter is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Sonmol Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-05-26 under 510(k) number K203196. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Peak flow meter?

Peak flow meter is a medical device that received FDA 510(k) clearance on 2021-05-26. The listed applicant is Shanghai Sonmol Medical Equipment Co., Ltd.. The 510(k) number is K203196.

When did Peak flow meter receive FDA 510(k) clearance?

Peak flow meter received FDA 510(k) clearance on 2021-05-26, under 510(k) number K203196.

Who is the listed applicant for Peak flow meter?

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

What is the FDA product code for Peak flow meter?

The FDA product code for Peak flow meter is BZH.

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Peak flow meter

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관련 기기 (코드: BZH)

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