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FDA 510(k)

Swift System

K-Number: K181941 · 2018-10-18

ApplicantEmblation , Ltd.
Decision Date2018-10-18
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Swift System is a medical device manufactured by Emblation , Ltd.. It received FDA 510(k) clearance on 2018-10-18 under approval number K181941. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Swift System?

Swift System is a medical device that received FDA 510(k) clearance on 2018-10-18. It is manufactured by Emblation , Ltd.. The 510(k) number is K181941.

When was Swift System approved by the FDA?

Swift System received FDA 510(k) clearance on 2018-10-18, under approval number K181941.

What company makes Swift System?

Swift System is manufactured by Emblation , Ltd..

What is the FDA product code for Swift System?

The FDA product code for Swift System is NEY.

Other Devices by Emblation , Ltd.

K222388swiftPro System

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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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