FDA 510(k)

Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device

Número K: K192001 · 2019-10-22

Data da decisão2019-10-22

Código do produtoFRC

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device is the device name listed in this FDA 510(k) record. The listed applicant is Sterilucent, Inc.. It received FDA 510(k) clearance on 2019-10-22 under 510(k) number K192001. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device?

Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device is a medical device that received FDA 510(k) clearance on 2019-10-22. The listed applicant is Sterilucent, Inc.. The 510(k) number is K192001.

When did Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device receive FDA 510(k) clearance?

Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device received FDA 510(k) clearance on 2019-10-22, under 510(k) number K192001.

Who is the listed applicant for Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device?

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

What is the FDA product code for Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device?

The FDA product code for Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device is FRC.

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Outros registros que listam Sterilucent, Inc. como candidato(a)

K191999Sterilucent VH2O2 Chemical Indicators K190005Sterilucent HC 80TT Hydrogen Peroxide Sterilizer

Dispositivos Relacionados (Código: FRC)

K260766Celerity 5 HP Biological Indicator (LCB052)STERIS Corporation K252680Celerity™ 20 HP Biological IndicatorSTERIS Corporation K251122Terragene® Bionova® BT20 Biological IndicatorTerragene K251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)Steris K250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)STERIS Corporation K250061Celerity IncubatorSTERIS Corporation

Fonte oficial

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