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FDA 510(k)

SDC3 HD Information Management System with Wireless Device Control Capability

K-Number: K210584 · 2021-03-18

ApplicantStryker
Decision Date2021-03-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SDC3 HD Information Management System with Wireless Device Control Capability is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2021-03-18 under 510(k) number K210584. 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 SDC3 HD Information Management System with Wireless Device Control Capability?

SDC3 HD Information Management System with Wireless Device Control Capability is a medical device that received FDA 510(k) clearance on 2021-03-18. The listed applicant is Stryker. The 510(k) number is K210584.

When did SDC3 HD Information Management System with Wireless Device Control Capability receive FDA 510(k) clearance?

SDC3 HD Information Management System with Wireless Device Control Capability received FDA 510(k) clearance on 2021-03-18, under 510(k) number K210584.

Who is the listed applicant for SDC3 HD Information Management System with Wireless Device Control Capability?

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 SDC3 HD Information Management System with Wireless Device Control Capability?

The FDA product code for SDC3 HD Information Management System with Wireless Device Control Capability 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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