swiftPro System
K-Number: K240518 · 2024-04-23
ApplicantEmblation Limited
Decision Date2024-04-23
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
swiftPro System is a medical device manufactured by Emblation Limited. It received FDA 510(k) clearance on 2024-04-23 under approval number K240518. 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 2024-04-23. It is manufactured by Emblation Limited. The 510(k) number is K240518.
When was swiftPro System approved by the FDA?
swiftPro System received FDA 510(k) clearance on 2024-04-23, under approval number K240518.
What company makes swiftPro System?
swiftPro System is manufactured by Emblation Limited.
What is the FDA product code for swiftPro System?
The FDA product code for swiftPro System is NEY.
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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.