FDA 510(k)

자동 지속 유출 샌트 시스템 (ACES 시스템)

K-번호: K231096 · 2023-08-18

결정일2023-08-18

제품 코드KPM

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Automatic Continuous Effusion Shunt (ACES) System ACES System is the device name listed in this FDA 510(k) record. The listed applicant is Pleural Dynamics, Inc.. It received FDA 510(k) clearance on 2023-08-18 under 510(k) number K231096. The device is classified under product code KPM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Automatic Continuous Effusion Shunt (ACES) System ACES System?

Automatic Continuous Effusion Shunt (ACES) System ACES System is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Pleural Dynamics, Inc.. The 510(k) number is K231096.

When did Automatic Continuous Effusion Shunt (ACES) System ACES System receive FDA 510(k) clearance?

Automatic Continuous Effusion Shunt (ACES) System ACES System received FDA 510(k) clearance on 2023-08-18, under 510(k) number K231096.

Who is the listed applicant for Automatic Continuous Effusion Shunt (ACES) System ACES System?

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

What is the FDA product code for Automatic Continuous Effusion Shunt (ACES) System ACES System?

The FDA product code for Automatic Continuous Effusion Shunt (ACES) System ACES System is KPM.

공식 출처

FDA 데이터베이스에서 보기 →

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

자동 지속 유출 샌트 시스템 (ACES 시스템)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: KPM)

공식 출처