FDA 510(k)

TGS Universal Headrest with Mounting Arm

K-Number: K193502 · 2020-02-14

Decision Date2020-02-14

Product CodePGW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

TGS Universal Headrest with Mounting Arm is a medical device manufactured by Stryker Ent. It received FDA 510(k) clearance on 2020-02-14 under approval number K193502. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TGS Universal Headrest with Mounting Arm?

TGS Universal Headrest with Mounting Arm is a medical device that received FDA 510(k) clearance on 2020-02-14. It is manufactured by Stryker Ent. The 510(k) number is K193502.

When was TGS Universal Headrest with Mounting Arm approved by the FDA?

TGS Universal Headrest with Mounting Arm received FDA 510(k) clearance on 2020-02-14, under approval number K193502.

What company makes TGS Universal Headrest with Mounting Arm?

TGS Universal Headrest with Mounting Arm is manufactured by Stryker Ent.

What is the FDA product code for TGS Universal Headrest with Mounting Arm?

The FDA product code for TGS Universal Headrest with Mounting Arm is PGW.

Other Devices by Stryker Ent

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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.