FDA 510(k)

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

N.º K: K200577 · 2020-04-03

Fecha de decisión2020-04-03

Código de productoNVE

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the 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 2020-04-03 under 510(k) number K200577. 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, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector?

RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector is a medical device that received FDA 510(k) clearance on 2020-04-03. The listed applicant is STERIS Corporation. The 510(k) number is K200577.

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

RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector received FDA 510(k) clearance on 2020-04-03, under 510(k) number K200577.

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

The FDA product code for RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the 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 K203199RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of 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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