FDA 510(k)

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus

N.º K: K221836 · 2022-12-07

Fecha de decisión2022-12-07

Código de productoCAH

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus is the device name listed in this FDA 510(k) record. The listed applicant is Drägerwerk AG & Co. KGaA. It received FDA 510(k) clearance on 2022-12-07 under 510(k) number K221836. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus?

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus is a medical device that received FDA 510(k) clearance on 2022-12-07. The listed applicant is Drägerwerk AG & Co. KGaA. The 510(k) number is K221836.

When did Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus receive FDA 510(k) clearance?

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus received FDA 510(k) clearance on 2022-12-07, under 510(k) number K221836.

Who is the listed applicant for Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus?

The FDA 510(k) record lists Drägerwerk AG & Co. KGaA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus?

The FDA product code for Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus is CAH.

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Otros registros que enlistan a Drägerwerk AG & Co. KGaA como solicitante

K251619Babyleo TN500 K252827IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)

Dispositivos relacionados (Código: CAH)

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.