FDA 510(k)

Signa Voyager, Signa Voyager Quantum

K号: K192426 · 2019-10-01

申请人Ge Healthcare (Tianjin) Company Limited

决定日期2019-10-01

产品代码LNH

咨询委员会RA

决定实质等同

器械摘要

Signa Voyager, Signa Voyager Quantum is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare (Tianjin) Company Limited. It received FDA 510(k) clearance on 2019-10-01 under 510(k) number K192426. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Signa Voyager, Signa Voyager Quantum?

Signa Voyager, Signa Voyager Quantum is a medical device that received FDA 510(k) clearance on 2019-10-01. The listed applicant is Ge Healthcare (Tianjin) Company Limited. The 510(k) number is K192426.

When did Signa Voyager, Signa Voyager Quantum receive FDA 510(k) clearance?

Signa Voyager, Signa Voyager Quantum received FDA 510(k) clearance on 2019-10-01, under 510(k) number K192426.

Who is the listed applicant for Signa Voyager, Signa Voyager Quantum?

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

What is the FDA product code for Signa Voyager, Signa Voyager Quantum?

The FDA product code for Signa Voyager, Signa Voyager Quantum is LNH.

列明Ge Healthcare (Tianjin) Company Limited为申报人的其他记录

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