FDA 510(k)

빠른 바로스타트 백(Rapid Barostat Bag, RBB) 펌프 및 캡시터

K-번호: K160287 · 2017-03-14

결정일2017-03-14

제품 코드FFX

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Rapid Barostat Bag (RBB) Pump and Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Mui Scientific. It received FDA 510(k) clearance on 2017-03-14 under 510(k) number K160287. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Rapid Barostat Bag (RBB) Pump and Catheter?

Rapid Barostat Bag (RBB) Pump and Catheter is a medical device that received FDA 510(k) clearance on 2017-03-14. The listed applicant is Mui Scientific. The 510(k) number is K160287.

When did Rapid Barostat Bag (RBB) Pump and Catheter receive FDA 510(k) clearance?

Rapid Barostat Bag (RBB) Pump and Catheter received FDA 510(k) clearance on 2017-03-14, under 510(k) number K160287.

Who is the listed applicant for Rapid Barostat Bag (RBB) Pump and Catheter?

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

What is the FDA product code for Rapid Barostat Bag (RBB) Pump and Catheter?

The FDA product code for Rapid Barostat Bag (RBB) Pump and Catheter is FFX.

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빠른 바로스타트 백(Rapid Barostat Bag, RBB) 펌프 및 캡시터

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: FFX)

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