FDA 510(k)

Celeridad HP Indicador Químico (CI)

N.º K: K183295 · 2019-01-04

Fecha de decisión2019-01-04

Código de productoJOJ

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Celerity HP Chemical Indicator (CI) is the device name listed in this FDA 510(k) record. The listed applicant is Steris Corporations. It received FDA 510(k) clearance on 2019-01-04 under 510(k) number K183295. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Celerity HP Chemical Indicator (CI)?

Celerity HP Chemical Indicator (CI) is a medical device that received FDA 510(k) clearance on 2019-01-04. The listed applicant is Steris Corporations. The 510(k) number is K183295.

When did Celerity HP Chemical Indicator (CI) receive FDA 510(k) clearance?

Celerity HP Chemical Indicator (CI) received FDA 510(k) clearance on 2019-01-04, under 510(k) number K183295.

Who is the listed applicant for Celerity HP Chemical Indicator (CI)?

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

What is the FDA product code for Celerity HP Chemical Indicator (CI)?

The FDA product code for Celerity HP Chemical Indicator (CI) is JOJ.

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Otros registros que enlistan a Steris Corporations como solicitante

K203630BioGuard Válvulas de Aire/Agua y Succión K190104SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System K183300VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack K182931VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag K180342SYSTEM 1E Liquid Chemical Sterilant Processing System K172748VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack

Ver todos los 7 dispositivos →

Dispositivos relacionados (Código: JOJ)

K2619923M™ Attest™ Integrador de Vapor y Químico (1243A, 1243B, 1243RE, 1243RES)Solventum US, LLC K260181LF Process Indicator Tape for Steam SterilizationIntertape Polymer Group K251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.K251035DISINTEK™ Pruebas de Cinta PASerim Research K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation K243876VERIFY STEAM Integrating IndicatorSTERIS 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.