FDA 510(k)

긴급 치료 모음 패키지 및 기흉 감지 AI 알고리즘, 긴급 치료 모음 2.1, 긴급 치료 모음

K-번호: K223491 · 2023-05-25

결정일2023-05-25

제품 코드QBS

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

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기기 요약

Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2023-05-25 under 510(k) number K223491. The device is classified under product code QBS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite?

Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite is a medical device that received FDA 510(k) clearance on 2023-05-25. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K223491.

When did Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite receive FDA 510(k) clearance?

Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite received FDA 510(k) clearance on 2023-05-25, under 510(k) number K223491.

Who is the listed applicant for Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite?

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

What is the FDA product code for Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite?

The FDA product code for Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite is QBS.

Ge Medical Systems, LLC를 신청인으로 등재한 기타 기록

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