Optima XR240amx
K-Number: K162990 · 2016-11-15
Device Summary
Frequently Asked Questions
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.
Other records listing Ge Medical Systems, LLC as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: IZL)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.