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FDA 510(k)

Personal Kinetigraph (PKG) System

K-Number: K161717 · 2016-09-20

ApplicantGkc Manufacturing Pty, Ltd.
Decision Date2016-09-20
Product CodeGYD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Personal Kinetigraph (PKG) System is the device name listed in this FDA 510(k) record. The listed applicant is Gkc Manufacturing Pty, Ltd.. It received FDA 510(k) clearance on 2016-09-20 under 510(k) number K161717. 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?

Personal Kinetigraph (PKG) System is a medical device that received FDA 510(k) clearance on 2016-09-20. The listed applicant is Gkc Manufacturing Pty, Ltd.. The 510(k) number is K161717.

When did Personal Kinetigraph (PKG) System receive FDA 510(k) clearance?

Personal Kinetigraph (PKG) System received FDA 510(k) clearance on 2016-09-20, under 510(k) number K161717.

Who is the listed applicant for Personal Kinetigraph (PKG) System?

The FDA 510(k) record lists Gkc Manufacturing Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Gkc Manufacturing Pty, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211887Personal Kinetigraph (PKG) System Gen 2 Plus

Related Devices (Code: GYD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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