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510(k) K242063

LibAirty Airway Clearance System by Synchrony Medical , Ltd. — Product Code BYI

K242063 is an FDA 510(k) premarket notification submitted by Synchrony Medical , Ltd. for the device "LibAirty Airway Clearance System". The FDA issued a decision of Substantially Equivalent on December 19, 2024. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2024
Date Received
July 15, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Percussor, Powered-Electric
Device Class
Class II
Regulation Number
868.5665
Review Panel
AN
Submission Type

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FDA data resources