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FDA 510(k)

Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter

N.º K: K202459 · 2021-09-26

SolicitantePharma System AB
Fecha de decisión2021-09-26
Código de productoCAH
Comité asesorAN
DecisiónSubstantially Equivalent

Resumen del dispositivo

Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter is the device name listed in this FDA 510(k) record. The listed applicant is Pharma System AB. It received FDA 510(k) clearance on 2021-09-26 under 510(k) number K202459. 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 Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter?

Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter is a medical device that received FDA 510(k) clearance on 2021-09-26. The listed applicant is Pharma System AB. The 510(k) number is K202459.

When did Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter receive FDA 510(k) clearance?

Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter received FDA 510(k) clearance on 2021-09-26, under 510(k) number K202459.

Who is the listed applicant for Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter?

The FDA 510(k) record lists Pharma System AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter?

The FDA product code for Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter is CAH.

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Fuente oficial

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

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