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FDA 510(k)

swiftPro System

K-Number: K222388 · 2023-05-04

ApplicantEmblation , Ltd.
Decision Date2023-05-04
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

swiftPro System is a medical device manufactured by Emblation , Ltd.. It received FDA 510(k) clearance on 2023-05-04 under approval number K222388. 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 swiftPro System?

swiftPro System is a medical device that received FDA 510(k) clearance on 2023-05-04. It is manufactured by Emblation , Ltd.. The 510(k) number is K222388.

When was swiftPro System approved by the FDA?

swiftPro System received FDA 510(k) clearance on 2023-05-04, under approval number K222388.

What company makes swiftPro System?

swiftPro System is manufactured by Emblation , Ltd..

What is the FDA product code for swiftPro System?

The FDA product code for swiftPro System is NEY.

Other Devices by Emblation , Ltd.

K181941Swift 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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