FDA 510(k)

1L Flexoval ® 병에 포장된吸入용 무균수.

K-번호: K223551 · 2023-08-03

결정일2023-08-03

제품 코드BTT

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

Sterile Water for Inhalation in 1L Flexoval ® bottles. is the device name listed in this FDA 510(k) record. The listed applicant is Hometa, Inc.. It received FDA 510(k) clearance on 2023-08-03 under 510(k) number K223551. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Sterile Water for Inhalation in 1L Flexoval ® bottles.?

Sterile Water for Inhalation in 1L Flexoval ® bottles. is a medical device that received FDA 510(k) clearance on 2023-08-03. The listed applicant is Hometa, Inc.. The 510(k) number is K223551.

When did Sterile Water for Inhalation in 1L Flexoval ® bottles. receive FDA 510(k) clearance?

Sterile Water for Inhalation in 1L Flexoval ® bottles. received FDA 510(k) clearance on 2023-08-03, under 510(k) number K223551.

Who is the listed applicant for Sterile Water for Inhalation in 1L Flexoval ® bottles.?

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

What is the FDA product code for Sterile Water for Inhalation in 1L Flexoval ® bottles.?

The FDA product code for Sterile Water for Inhalation in 1L Flexoval ® bottles. is BTT.

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FDA 데이터베이스에서 보기 →

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

1L Flexoval ® 병에 포장된吸入용 무균수.

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: BTT)

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