FDA 510(k)

RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector

N.º K: K203199 · 2020-12-01

Fecha de decisión2020-12-01

Código de productoNVE

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2020-12-01 under 510(k) number K203199. The device is classified under product code NVE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector?

RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector is a medical device that received FDA 510(k) clearance on 2020-12-01. The listed applicant is STERIS Corporation. The 510(k) number is K203199.

When did RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector receive FDA 510(k) clearance?

RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector received FDA 510(k) clearance on 2020-12-01, under 510(k) number K203199.

Who is the listed applicant for RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector?

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

What is the FDA product code for RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector?

The FDA product code for RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector is NVE.

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Otros registros que enlistan a STERIS Corporation como solicitante

K261055AMSCO 700 Steam Sterilizer K260766Celerity 5 HP Biological Indicator (LCB052)K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 K252680Celerity™ 20 HP Biological Indicator K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 K243876VERIFY STEAM Integrating Indicator

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Dispositivos relacionados (Código: NVE)

K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Baja Temperatura Sistema de Esterilización, V-PRO s2 Baja Temperatura Sistema de Esterilización, V-PRO 60 Baja Temperatura Sistema de Esterilización, RAS 12 Rack, RAS 12 Long Rack, Ciclo RAS del AMSCO 7052HP y 7053HP Single Chamber Washer DisinfectorSteris K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Baja Temperatura Sistema de Esterilización, V-PRO s2 Baja Temperatura Sistema de Esterilización, RAS 12 Rack, RAS 12 Long Rack, Ciclo RAS del AMSCO 7052HP y 7053HP Single Chamber Washer DisinfectorSteris K200577RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/DisinfectorSTERIS Corporation K190081RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/DisinfectorSTERIS Corporation

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.