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FDA 510(k)

Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control

Número K: K232157 · 2023-08-18

RequerenteStryker Corporation
Data da decisão2023-08-18
Código do produtoGCJ
Comité consultivoGU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2023-08-18 under 510(k) number K232157. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control?

Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Stryker Corporation. The 510(k) number is K232157.

When did Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control receive FDA 510(k) clearance?

Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control received FDA 510(k) clearance on 2023-08-18, under 510(k) number K232157.

Who is the listed applicant for Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control?

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

What is the FDA product code for Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control?

The FDA product code for Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control is GCJ.

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Fonte oficial

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