FDA 510(k)

Xprecia Prime Coagulation System

K-번호: K230802 · 2024-03-15

결정일2024-03-15

제품 코드GJS

자문 위원회HE

결정Substantially Equivalent

기기 요약

Xprecia Prime Coagulation System is the device name listed in this FDA 510(k) record. The listed applicant is Universal Biosensors Pty, Ltd.. It received FDA 510(k) clearance on 2024-03-15 under 510(k) number K230802. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Xprecia Prime Coagulation System?

Xprecia Prime Coagulation System is a medical device that received FDA 510(k) clearance on 2024-03-15. The listed applicant is Universal Biosensors Pty, Ltd.. The 510(k) number is K230802.

When did Xprecia Prime Coagulation System receive FDA 510(k) clearance?

Xprecia Prime Coagulation System received FDA 510(k) clearance on 2024-03-15, under 510(k) number K230802.

Who is the listed applicant for Xprecia Prime Coagulation System?

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

What is the FDA product code for Xprecia Prime Coagulation System?

The FDA product code for Xprecia Prime Coagulation System is GJS.

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Xprecia Prime Coagulation System

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: GJS)

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