FDA 510(k)

VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems

Numéro K : K233654 · 2023-12-08

DemandeurSteris

Date de décision2023-12-08

Code produitJOJ

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is the device name listed in this FDA 510(k) record. The listed applicant is Steris. It received FDA 510(k) clearance on 2023-12-08 under 510(k) number K233654. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems?

VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is a medical device that received FDA 510(k) clearance on 2023-12-08. The listed applicant is Steris. The 510(k) number is K233654.

When did VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems receive FDA 510(k) clearance?

VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems received FDA 510(k) clearance on 2023-12-08, under 510(k) number K233654.

Who is the listed applicant for VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems?

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 VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems?

The FDA product code for VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is JOJ.

Essais cliniques associés

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Dispositifs connexes (Code : JOJ)

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Source officielle

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