FDA 510(k)

Reprocesador de Endoscopios AEROFLEX(TM) Automático con Monitor AUTOSURE(TM) MRC

N.º K: K181472 · 2019-04-23

SolicitanteAdvanced Sterilization Products (Asp)

Fecha de decisión2019-04-23

Código de productoFEB

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products (Asp). It received FDA 510(k) clearance on 2019-04-23 under 510(k) number K181472. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor?

AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor is a medical device that received FDA 510(k) clearance on 2019-04-23. The listed applicant is Advanced Sterilization Products (Asp). The 510(k) number is K181472.

When did AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor receive FDA 510(k) clearance?

AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor received FDA 510(k) clearance on 2019-04-23, under 510(k) number K181472.

Who is the listed applicant for AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor?

The FDA 510(k) record lists Advanced Sterilization Products (Asp) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor?

The FDA product code for AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor is FEB.

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Dispositivos relacionados (Código: FEB)

K241168System 83 Revolve Endoscope Washer/DisinfectorWassenburg Medical, Inc.K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS Corporation K230930enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemSTERIS Corporation K213833SCOPE BUDDY PLUS Endoscope Flushing AidMedivators, Inc.K201920Endoscope Reprocessor OER-EliteOlympus Medical Systems Corp.K173590System 83 Plus Washer/DisinfectorCustom Ultrasonics, Inc.

Fuente oficial

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