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FDA 510(k)

LibAirty Airway Clearance System

K-Number: K242063 · 2024-12-19

ApplicantSynchrony Medical , Ltd.
Decision Date2024-12-19
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LibAirty Airway Clearance System is a medical device manufactured by Synchrony Medical , Ltd.. It received FDA 510(k) clearance on 2024-12-19 under approval number K242063. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LibAirty Airway Clearance System?

LibAirty Airway Clearance System is a medical device that received FDA 510(k) clearance on 2024-12-19. It is manufactured by Synchrony Medical , Ltd.. The 510(k) number is K242063.

When was LibAirty Airway Clearance System approved by the FDA?

LibAirty Airway Clearance System received FDA 510(k) clearance on 2024-12-19, under approval number K242063.

What company makes LibAirty Airway Clearance System?

LibAirty Airway Clearance System is manufactured by Synchrony Medical , Ltd..

What is the FDA product code for LibAirty Airway Clearance System?

The FDA product code for LibAirty Airway Clearance System is BYI.

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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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