Game Ready GRPro 2.1 System— 510(k) K192114

Name: FDA 510(k) clearance K192114
Creator: U.S. Food and Drug Administration
Published: 2019-10-29

Substantially Equivalent

Cool Systems, Inc. (Dba Game Ready)

FDA 510(k) clearance K192114 for Game Ready GRPro 2.1 System, Substantially Equivalent on 2019-10-29. Applicant: Cool Systems, Inc. (Dba Game Ready). Device class: 2.

Clearance details

Applicant: Cool Systems, Inc. (Dba Game Ready)
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2019-08-06
Decision date: 2019-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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