FDA 510(k)

SDC3 HD Information Management System with Wireless Device Control Capability

K-Number: K210584 · 2021-03-18

Decision Date2021-03-18

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SDC3 HD Information Management System with Wireless Device Control Capability is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2021-03-18 under approval 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. It is manufactured by Stryker. The 510(k) number is K210584.

When was SDC3 HD Information Management System with Wireless Device Control Capability approved by the FDA?

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

What company makes SDC3 HD Information Management System with Wireless Device Control Capability?

SDC3 HD Information Management System with Wireless Device Control Capability is manufactured by Stryker.

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

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