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FDA 510(k)

Connected OR Hub with Voice Control, Connected OR Hub with Device Control

K-Number: K201434 · 2020-07-28

ApplicantStryker
Decision Date2020-07-28
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Connected OR Hub with Voice Control, Connected OR Hub with Device Control is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2020-07-28 under 510(k) number K201434. 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 Voice Control, Connected OR Hub with Device Control?

Connected OR Hub with Voice Control, Connected OR Hub with Device Control is a medical device that received FDA 510(k) clearance on 2020-07-28. The listed applicant is Stryker. The 510(k) number is K201434.

When did Connected OR Hub with Voice Control, Connected OR Hub with Device Control receive FDA 510(k) clearance?

Connected OR Hub with Voice Control, Connected OR Hub with Device Control received FDA 510(k) clearance on 2020-07-28, under 510(k) number K201434.

Who is the listed applicant for Connected OR Hub with Voice Control, Connected OR Hub with Device 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 Connected OR Hub with Voice Control, Connected OR Hub with Device Control?

The FDA product code for Connected OR Hub with Voice Control, Connected OR Hub with Device 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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