FDA 510(k)

Optima XR240amx

K-Number: K162990 · 2016-11-15

Decision Date2016-11-15

Product CodeIZL

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Optima XR240amx?

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

When was Optima XR240amx approved by the FDA?

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

What company makes Optima XR240amx?

Optima XR240amx is manufactured by Ge Medical Systems, LLC.

What is the FDA product code for Optima XR240amx?

The FDA product code for Optima XR240amx is IZL.

Other Devices by Ge Medical Systems, LLC

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.