FDA 510(k)

Acuson Freestyle 超声系统

K号: K171766 · 2017-07-12

决定日期2017-07-12

产品代码IYO

咨询委员会RA

决定实质等同

器械摘要

Acuson SC2000 Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2017-07-12 under 510(k) number K171766. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Acuson SC2000 Diagnostic Ultrasound System?

Acuson SC2000 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-07-12. The listed applicant is Siemens Medi Cal Solutions, Inc.. The 510(k) number is K171766.

When did Acuson SC2000 Diagnostic Ultrasound System receive FDA 510(k) clearance?

Acuson SC2000 Diagnostic Ultrasound System received FDA 510(k) clearance on 2017-07-12, under 510(k) number K171766.

Who is the listed applicant for Acuson SC2000 Diagnostic Ultrasound System?

The FDA 510(k) record lists Siemens Medi Cal Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Acuson SC2000 Diagnostic Ultrasound System?

The FDA product code for Acuson SC2000 Diagnostic Ultrasound System is IYO.

列明Siemens Medi Cal Solutions, Inc.为申报人的其他记录

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