FDA 510(k)

Senographe Pristina

K号: K211725 · 2021-08-06

决定日期2021-08-06

产品代码MUE

咨询委员会RA

决定实质等同

器械摘要

Senographe Pristina is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2021-08-06 under 510(k) number K211725. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Senographe Pristina?

Senographe Pristina is a medical device that received FDA 510(k) clearance on 2021-08-06. The listed applicant is GE Healthcare. The 510(k) number is K211725.

When did Senographe Pristina receive FDA 510(k) clearance?

Senographe Pristina received FDA 510(k) clearance on 2021-08-06, under 510(k) number K211725.

Who is the listed applicant for Senographe Pristina?

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

What is the FDA product code for Senographe Pristina?

The FDA product code for Senographe Pristina is MUE.

列明GE Healthcare为申报人的其他记录

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