Personal Kinetigraph (PKG) System Gen 2 Plus— 510(k) K211887

Name: FDA 510(k) clearance K211887
Creator: U.S. Food and Drug Administration
Published: 2022-03-11

Substantially Equivalent

Gkc Manufacturing Pty, Ltd.

FDA 510(k) clearance K211887 for Personal Kinetigraph (PKG) System Gen 2 Plus, Substantially Equivalent on 2022-03-11. Applicant: Gkc Manufacturing Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Gkc Manufacturing Pty, Ltd.
Product code: Code GYD
Device class: Class 2
Regulation: 21 CFR 882.1950
Advisory panel: Neurology
Date received: 2021-06-21
Decision date: 2022-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, AU

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.