FDA 510(k)

Monarch Airway Clearance System

Número K: K173603 · 2018-10-24

Data da decisão2018-10-24

Código do produtoBYI

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Monarch Airway Clearance System is the device name listed in this FDA 510(k) record. The listed applicant is Hill-Rom Holdings, Inc.. It received FDA 510(k) clearance on 2018-10-24 under 510(k) number K173603. 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 Monarch Airway Clearance System?

Monarch Airway Clearance System is a medical device that received FDA 510(k) clearance on 2018-10-24. The listed applicant is Hill-Rom Holdings, Inc.. The 510(k) number is K173603.

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

Monarch Airway Clearance System received FDA 510(k) clearance on 2018-10-24, under 510(k) number K173603.

Who is the listed applicant for Monarch Airway Clearance System?

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

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

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

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