FDA 510(k)

enspire 3000 Cleaning and Liquid Chemical Sterile Processing System

N.º K: K230930 · 2023-06-30

Fecha de decisión2023-06-30

Código de productoFEB

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

enspire 3000 Cleaning and Liquid Chemical Sterile Processing System is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2023-06-30 under 510(k) number K230930. 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 enspire 3000 Cleaning and Liquid Chemical Sterile Processing System?

enspire 3000 Cleaning and Liquid Chemical Sterile Processing System is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is STERIS Corporation. The 510(k) number is K230930.

When did enspire 3000 Cleaning and Liquid Chemical Sterile Processing System receive FDA 510(k) clearance?

enspire 3000 Cleaning and Liquid Chemical Sterile Processing System received FDA 510(k) clearance on 2023-06-30, under 510(k) number K230930.

Who is the listed applicant for enspire 3000 Cleaning and Liquid Chemical Sterile Processing System?

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 enspire 3000 Cleaning and Liquid Chemical Sterile Processing System?

The FDA product code for enspire 3000 Cleaning and Liquid Chemical Sterile Processing System is FEB.

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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: FEB)

K241168System 83 Revolve Endoscope Washer/DisinfectorWassenburg Medical, Inc.K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS Corporation K213833SCOPE BUDDY PLUS Endoscope Flushing AidMedivators, Inc.K201920Endoscope Reprocessor OER-EliteOlympus Medical Systems Corp.K173590System 83 Plus Washer/DisinfectorCustom Ultrasonics, Inc.K190969ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp.

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.