FDA 510(k)

Optima XR240amx

K号: K162990 · 2016-11-15

决定日期2016-11-15

产品代码IZL

咨询委员会RA

决定Substantially Equivalent

器械摘要

Optima XR240amx is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K162990. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Optima XR240amx?

Optima XR240amx is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K162990.

When did Optima XR240amx receive FDA 510(k) clearance?

Optima XR240amx received FDA 510(k) clearance on 2016-11-15, under 510(k) number K162990.

Who is the listed applicant for Optima XR240amx?

The FDA 510(k) record lists Ge Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optima XR240amx?

The FDA product code for Optima XR240amx is IZL.

列明Ge Medical Systems, LLC为申报人的其他记录

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