FDA 510(k)

보니옥스 X-1 APD 케이클러; 보니옥스 자동 PD 세트 DS-1

K-번호: K243371 · 2025-05-16

결정일2025-05-16

제품 코드FKX

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 is the device name listed in this FDA 510(k) record. The listed applicant is Byonyks Pvt, Ltd.. It received FDA 510(k) clearance on 2025-05-16 under 510(k) number K243371. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1?

Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 is a medical device that received FDA 510(k) clearance on 2025-05-16. The listed applicant is Byonyks Pvt, Ltd.. The 510(k) number is K243371.

When did Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 receive FDA 510(k) clearance?

Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 received FDA 510(k) clearance on 2025-05-16, under 510(k) number K243371.

Who is the listed applicant for Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1?

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

What is the FDA product code for Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1?

The FDA product code for Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 is FKX.

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FDA 데이터베이스에서 보기 →

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

보니옥스 X-1 APD 케이클러; 보니옥스 자동 PD 세트 DS-1

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: FKX)

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