FDA 510(k)

Sterisystem Dry-Base Instrument Tray

Número K: K203177 · 2022-01-02

Data da decisão2022-01-02

Código do produtoKCT

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterisystem Dry-Base Instrument Tray is the device name listed in this FDA 510(k) record. The listed applicant is O&M Halyard, Inc.. It received FDA 510(k) clearance on 2022-01-02 under 510(k) number K203177. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sterisystem Dry-Base Instrument Tray?

Sterisystem Dry-Base Instrument Tray is a medical device that received FDA 510(k) clearance on 2022-01-02. The listed applicant is O&M Halyard, Inc.. The 510(k) number is K203177.

When did Sterisystem Dry-Base Instrument Tray receive FDA 510(k) clearance?

Sterisystem Dry-Base Instrument Tray received FDA 510(k) clearance on 2022-01-02, under 510(k) number K203177.

Who is the listed applicant for Sterisystem Dry-Base Instrument Tray?

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

What is the FDA product code for Sterisystem Dry-Base Instrument Tray?

The FDA product code for Sterisystem Dry-Base Instrument Tray is KCT.

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