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FDA 510(k)

ConnectedOR Hub with Device and Voice Control

K-Number: K181258 · 2018-11-05

ApplicantStryker
Decision Date2018-11-05
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ConnectedOR Hub with Device and Voice Control is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2018-11-05 under approval number K181258. 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 ConnectedOR Hub with Device and Voice Control?

ConnectedOR Hub with Device and Voice Control is a medical device that received FDA 510(k) clearance on 2018-11-05. It is manufactured by Stryker. The 510(k) number is K181258.

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

ConnectedOR Hub with Device and Voice Control received FDA 510(k) clearance on 2018-11-05, under approval number K181258.

What company makes ConnectedOR Hub with Device and Voice Control?

ConnectedOR Hub with Device and Voice Control is manufactured by Stryker.

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

The FDA product code for ConnectedOR Hub 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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