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FDA 510(k)

Connected OR Hub with Device and Voice Control

K-Number: K192172 · 2019-09-09

ApplicantStryker
Decision Date2019-09-09
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Connected OR Hub with Device and Voice Control is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2019-09-09 under approval number K192172. 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?

Connected OR Hub with Device and Voice Control is a medical device that received FDA 510(k) clearance on 2019-09-09. It is manufactured by Stryker. The 510(k) number is K192172.

When was Connected OR Hub with Device and Voice Control approved by the FDA?

Connected OR Hub with Device and Voice Control received FDA 510(k) clearance on 2019-09-09, under approval number K192172.

What company makes Connected OR Hub with Device and Voice Control?

Connected OR Hub with Device and Voice Control is manufactured by Stryker.

What is the FDA product code for Connected OR Hub with Device and Voice Control?

The FDA product code for Connected OR Hub with Device and Voice Control is GCJ.

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Official Source

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