FDA 510(k)

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader

Número K: K192025 · 2020-01-23

RequerenteAdvanced Sterilization Products (Asp)

Data da decisão2020-01-23

Código do produtoFRC

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Sterilization Products (Asp). It received FDA 510(k) clearance on 2020-01-23 under 510(k) number K192025. 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 STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader?

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader is a medical device that received FDA 510(k) clearance on 2020-01-23. The listed applicant is Advanced Sterilization Products (Asp). The 510(k) number is K192025.

When did STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader receive FDA 510(k) clearance?

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader received FDA 510(k) clearance on 2020-01-23, under 510(k) number K192025.

Who is the listed applicant for STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader?

The FDA 510(k) record lists Advanced Sterilization Products (Asp) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader?

The FDA product code for STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader is FRC.

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Outros registros que listam Advanced Sterilization Products (Asp) como candidato(a)

K181472AEROFLEX(TM) Reprocessador Automático de Endoscópios com Monitor AUTOSURE(TM) MRC K182404STERRAD VELOCITY Biological Indicator K170039STERRAD VELOCITY Biological Indictator and Reader K152189EVOTECH ECR

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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