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FDA 510(k)

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

K-Number: K232157 · 2023-08-18

ApplicantStryker Corporation
Decision Date2023-08-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Stryker Corporation. The 510(k) number is K232157.

When was Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control approved by the FDA?

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 approval number K232157.

What company makes 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 manufactured by Stryker Corporation.

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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Related PubMed Literature

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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