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FDA 510(k)

Personal Kinetigraph (PKG) System Gen 2 Plus

K-Number: K211887 · 2022-03-11

ApplicantGkc Manufacturing Pty, Ltd.
Decision Date2022-03-11
Product CodeGYD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Personal Kinetigraph (PKG) System Gen 2 Plus is a medical device manufactured by Gkc Manufacturing Pty, Ltd.. It received FDA 510(k) clearance on 2022-03-11 under approval number K211887. The device is classified under product code GYD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Personal Kinetigraph (PKG) System Gen 2 Plus?

Personal Kinetigraph (PKG) System Gen 2 Plus is a medical device that received FDA 510(k) clearance on 2022-03-11. It is manufactured by Gkc Manufacturing Pty, Ltd.. The 510(k) number is K211887.

When was Personal Kinetigraph (PKG) System Gen 2 Plus approved by the FDA?

Personal Kinetigraph (PKG) System Gen 2 Plus received FDA 510(k) clearance on 2022-03-11, under approval number K211887.

What company makes Personal Kinetigraph (PKG) System Gen 2 Plus?

Personal Kinetigraph (PKG) System Gen 2 Plus is manufactured by Gkc Manufacturing Pty, Ltd..

What is the FDA product code for Personal Kinetigraph (PKG) System Gen 2 Plus?

The FDA product code for Personal Kinetigraph (PKG) System Gen 2 Plus is GYD.

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Other Devices by Gkc Manufacturing Pty, Ltd.

K161717Personal Kinetigraph (PKG) System

Related Devices (Code: GYD)

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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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