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FDA 510(k)

Falcon/Xpress (Falcon/Xpress)

K-Number: K242662 · 2024-12-18

ApplicantViasonix , Ltd.
Decision Date2024-12-18
Product CodeJOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Falcon/Xpress (Falcon/Xpress) is a medical device manufactured by Viasonix , Ltd.. It received FDA 510(k) clearance on 2024-12-18 under approval number K242662. The device is classified under product code JOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Falcon/Xpress (Falcon/Xpress)?

Falcon/Xpress (Falcon/Xpress) is a medical device that received FDA 510(k) clearance on 2024-12-18. It is manufactured by Viasonix , Ltd.. The 510(k) number is K242662.

When was Falcon/Xpress (Falcon/Xpress) approved by the FDA?

Falcon/Xpress (Falcon/Xpress) received FDA 510(k) clearance on 2024-12-18, under approval number K242662.

What company makes Falcon/Xpress (Falcon/Xpress)?

Falcon/Xpress (Falcon/Xpress) is manufactured by Viasonix , Ltd..

What is the FDA product code for Falcon/Xpress (Falcon/Xpress)?

The FDA product code for Falcon/Xpress (Falcon/Xpress) is JOP.

Other Devices by Viasonix , Ltd.

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Related Devices (Code: JOP)

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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.

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