FDA 510(k)

Getinge Assured MI Steam Migrating Integrator

Номер K: K200252 · 2020-05-21

Дата решения2020-05-21

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 Co, Inc.. It received FDA 510(k) clearance on 2020-05-21 under 510(k) number K200252. 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 2020-05-21. The listed applicant is Steritec Products Mfg Co, Inc.. The 510(k) number is K200252.

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 2020-05-21, under 510(k) number K200252.

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

The FDA 510(k) record lists Steritec Products Mfg Co, Inc. 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.