FDA 510(k)

Type 5 Integrating Indicator for Steam (CSPN-15)

Número K: K242860 · 2025-01-17

Data da decisão2025-01-17

Código do produtoJOJ

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Type 5 Integrating Indicator for Steam (CSPN-15) is the device name listed in this FDA 510(k) record. The listed applicant is True Indicating, LLC. It received FDA 510(k) clearance on 2025-01-17 under 510(k) number K242860. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Type 5 Integrating Indicator for Steam (CSPN-15)?

Type 5 Integrating Indicator for Steam (CSPN-15) is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is True Indicating, LLC. The 510(k) number is K242860.

When did Type 5 Integrating Indicator for Steam (CSPN-15) receive FDA 510(k) clearance?

Type 5 Integrating Indicator for Steam (CSPN-15) received FDA 510(k) clearance on 2025-01-17, under 510(k) number K242860.

Who is the listed applicant for Type 5 Integrating Indicator for Steam (CSPN-15)?

The FDA 510(k) record lists True Indicating, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Type 5 Integrating Indicator for Steam (CSPN-15)?

The FDA product code for Type 5 Integrating Indicator for Steam (CSPN-15) is JOJ.

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Outros registros que listam True Indicating, LLC como candidato(a)

K251559InstaTRU Instant Biological Indicator for Steam (IBI-05)K233413Ultraphon Chemical Indicator (TRO-T and TRO-B)K220778Chemical Indicator for Steam K210481Instant 20s Indicator K200970Self-Contained Biological Indicator

Dispositivos Relacionados (Código: 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

Fonte oficial

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