FDA 510(k)

LibAirty Airway Clearance System

Número K: K242063 · 2024-12-19

Data da decisão2024-12-19

Código do produtoBYI

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

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. The listed applicant is Synchrony Medical , Ltd.. The 510(k) number is K242063.

When did LibAirty Airway Clearance System receive FDA 510(k) clearance?

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

Who is the listed applicant for LibAirty Airway Clearance System?

The FDA 510(k) record lists Synchrony Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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