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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 the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2018-11-05 under 510(k) 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. The listed applicant is Stryker. The 510(k) number is K181258.

When did ConnectedOR Hub with Device and Voice Control receive FDA 510(k) clearance?

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

Who is the listed applicant for ConnectedOR Hub with Device and Voice Control?

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

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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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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