FDA 510(k)

Sistema de Desobstrução de Vias Aéreas Electromed SmartVest

Número K: K222496 · 2022-11-18

Data da decisão2022-11-18

Código do produtoBYI

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Electromed SmartVest Airway Clearance System is the device name listed in this FDA 510(k) record. The listed applicant is Electromed, Inc.. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K222496. 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 Electromed SmartVest Airway Clearance System?

Electromed SmartVest Airway Clearance System is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Electromed, Inc.. The 510(k) number is K222496.

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

Electromed SmartVest Airway Clearance System received FDA 510(k) clearance on 2022-11-18, under 510(k) number K222496.

Who is the listed applicant for Electromed SmartVest Airway Clearance System?

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

What is the FDA product code for Electromed SmartVest Airway Clearance System?

The FDA product code for Electromed SmartVest Airway Clearance System is BYI.

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