FDA 510(k)

Aerogen®Solo 압력 Nebulizer 시스템

K-번호: K232507 · 2024-05-10

결정일2024-05-10

제품 코드CAF

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기기 요약

Aerogen®Solo Nebulizer System is the device name listed in this FDA 510(k) record. The listed applicant is Aerogen, Ltd.. It received FDA 510(k) clearance on 2024-05-10 under 510(k) number K232507. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Aerogen®Solo Nebulizer System?

Aerogen®Solo Nebulizer System is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is Aerogen, Ltd.. The 510(k) number is K232507.

When did Aerogen®Solo Nebulizer System receive FDA 510(k) clearance?

Aerogen®Solo Nebulizer System received FDA 510(k) clearance on 2024-05-10, under 510(k) number K232507.

Who is the listed applicant for Aerogen®Solo Nebulizer System?

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

What is the FDA product code for Aerogen®Solo Nebulizer System?

The FDA product code for Aerogen®Solo Nebulizer System is CAF.

Aerogen, Ltd.를 신청인으로 등재한 기타 기록

K251615Aerogen Pro-X1 컨트롤러 시스템

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