FDA 510(k)

CELERITY 20 HP Challenge Pack

Número K: K220473 · 2022-03-18

RequerenteSteris

Data da decisão2022-03-18

Código do produtoFRC

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

CELERITY 20 HP Challenge Pack is the device name listed in this FDA 510(k) record. The listed applicant is Steris. It received FDA 510(k) clearance on 2022-03-18 under 510(k) number K220473. 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 CELERITY 20 HP Challenge Pack?

CELERITY 20 HP Challenge Pack is a medical device that received FDA 510(k) clearance on 2022-03-18. The listed applicant is Steris. The 510(k) number is K220473.

When did CELERITY 20 HP Challenge Pack receive FDA 510(k) clearance?

CELERITY 20 HP Challenge Pack received FDA 510(k) clearance on 2022-03-18, under 510(k) number K220473.

Who is the listed applicant for CELERITY 20 HP Challenge Pack?

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

What is the FDA product code for CELERITY 20 HP Challenge Pack?

The FDA product code for CELERITY 20 HP Challenge Pack is FRC.

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Outros registros que listam Steris como candidato(a)

K251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)K242773Electro Lube NXT K242189CELERITY HP Indicator Tape (PCC077)K241344MetriCide™ OPA Plus Solution Test Strip K241055Electro Lube NXT K240760CELERITY HP Indicator Tape

Ver todos os 19 dispositivos →

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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