FDA 510(k)

SIR-Spheres 마이크로스페어 활성 계산기 (SMAC)

K-번호: K202392 · 2020-10-23

결정일2020-10-23

제품 코드KPS

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

결정대체적으로 동일

기기 요약

SIR-Spheres Microspheres Activity Calculator (SMAC) is the device name listed in this FDA 510(k) record. The listed applicant is Sirtex Medical US Holdings, Inc.. It received FDA 510(k) clearance on 2020-10-23 under 510(k) number K202392. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the SIR-Spheres Microspheres Activity Calculator (SMAC)?

SIR-Spheres Microspheres Activity Calculator (SMAC) is a medical device that received FDA 510(k) clearance on 2020-10-23. The listed applicant is Sirtex Medical US Holdings, Inc.. The 510(k) number is K202392.

When did SIR-Spheres Microspheres Activity Calculator (SMAC) receive FDA 510(k) clearance?

SIR-Spheres Microspheres Activity Calculator (SMAC) received FDA 510(k) clearance on 2020-10-23, under 510(k) number K202392.

Who is the listed applicant for SIR-Spheres Microspheres Activity Calculator (SMAC)?

The FDA 510(k) record lists Sirtex Medical US Holdings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIR-Spheres Microspheres Activity Calculator (SMAC)?

The FDA product code for SIR-Spheres Microspheres Activity Calculator (SMAC) is KPS.

관련 기기 (코드: KPS)

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FDA 데이터베이스에서 보기 →

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

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: KPS)

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