FDA 510(k)

Getinge Assured MI Steam Migrating Integrator

Номер K: K242795 · 2024-10-15

ЗаявительSteritec Products Mfg. (A Getinge Group Company)

Дата решения2024-10-15

Код продуктаJOJ

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Getinge Assured MI Steam Migrating Integrator is the device name listed in this FDA 510(k) record. The listed applicant is Steritec Products Mfg. (A Getinge Group Company). It received FDA 510(k) clearance on 2024-10-15 under 510(k) number K242795. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Getinge Assured MI Steam Migrating Integrator?

Getinge Assured MI Steam Migrating Integrator is a medical device that received FDA 510(k) clearance on 2024-10-15. The listed applicant is Steritec Products Mfg. (A Getinge Group Company). The 510(k) number is K242795.

When did Getinge Assured MI Steam Migrating Integrator receive FDA 510(k) clearance?

Getinge Assured MI Steam Migrating Integrator received FDA 510(k) clearance on 2024-10-15, under 510(k) number K242795.

Who is the listed applicant for Getinge Assured MI Steam Migrating Integrator?

The FDA 510(k) record lists Steritec Products Mfg. (A Getinge Group Company) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Getinge Assured MI Steam Migrating Integrator?

The FDA product code for Getinge Assured MI Steam Migrating Integrator is JOJ.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: JOJ)

K2619923M™ Attest™ Steam Chemical Integrator (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™ PA Test StripsSerim Research K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS Corporation K243876VERIFY STEAM Integrating IndicatorSTERIS Corporation

Официальный источник

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