FDA 510(k)

ACUSON S3000 S2000 S1000 진단 초음파 시스템

K-번호: K172162 · 2017-08-16

결정일2017-08-16

제품 코드IYN

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

결정대체적으로 동일

기기 요약

ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare. It received FDA 510(k) clearance on 2017-08-16 under 510(k) number K172162. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems?

ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems is a medical device that received FDA 510(k) clearance on 2017-08-16. The listed applicant is Siemens Healthcare. The 510(k) number is K172162.

When did ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems receive FDA 510(k) clearance?

ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems received FDA 510(k) clearance on 2017-08-16, under 510(k) number K172162.

Who is the listed applicant for ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems?

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

What is the FDA product code for ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems?

The FDA product code for ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems is IYN.

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ACUSON S3000 S2000 S1000 진단 초음파 시스템

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: IYN)

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