FDA 510(k)

Crosstex VH2O2 Chemical Indicators

Номер K: K200096 · 2021-07-15

ЗаявительCrosstex International, Inc. (A Cantel Medical Company)

Дата решения2021-07-15

Код продуктаJOJ

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

Crosstex VH2O2 Chemical Indicators is the device name listed in this FDA 510(k) record. The listed applicant is Crosstex International, Inc. (A Cantel Medical Company). It received FDA 510(k) clearance on 2021-07-15 under 510(k) number K200096. 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 Crosstex VH2O2 Chemical Indicators?

Crosstex VH2O2 Chemical Indicators is a medical device that received FDA 510(k) clearance on 2021-07-15. The listed applicant is Crosstex International, Inc. (A Cantel Medical Company). The 510(k) number is K200096.

When did Crosstex VH2O2 Chemical Indicators receive FDA 510(k) clearance?

Crosstex VH2O2 Chemical Indicators received FDA 510(k) clearance on 2021-07-15, under 510(k) number K200096.

Who is the listed applicant for Crosstex VH2O2 Chemical Indicators?

The FDA 510(k) record lists Crosstex International, Inc. (A Cantel Medical Company) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Crosstex VH2O2 Chemical Indicators?

The FDA product code for Crosstex VH2O2 Chemical Indicators 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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