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FDA 510(k)

Inessa System

K-Number: K230545 · 2023-12-20

ApplicantTriple Jump Israel , Ltd.
Decision Date2023-12-20
Product CodeQFG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Inessa System is a medical device manufactured by Triple Jump Israel , Ltd.. It received FDA 510(k) clearance on 2023-12-20 under approval number K230545. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Inessa System?

Inessa System is a medical device that received FDA 510(k) clearance on 2023-12-20. It is manufactured by Triple Jump Israel , Ltd.. The 510(k) number is K230545.

When was Inessa System approved by the FDA?

Inessa System received FDA 510(k) clearance on 2023-12-20, under approval number K230545.

What company makes Inessa System?

Inessa System is manufactured by Triple Jump Israel , Ltd..

What is the FDA product code for Inessa System?

The FDA product code for Inessa System is QFG.

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Official Source

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