Game Ready GRPro 2.1 System
K-Number: K192114 · 2019-10-29
ApplicantCool Systems, Inc. (Dba Game Ready)
Decision Date2019-10-29
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Game Ready GRPro 2.1 System is a medical device manufactured by Cool Systems, Inc. (Dba Game Ready). It received FDA 510(k) clearance on 2019-10-29 under approval number K192114. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Game Ready GRPro 2.1 System?
Game Ready GRPro 2.1 System is a medical device that received FDA 510(k) clearance on 2019-10-29. It is manufactured by Cool Systems, Inc. (Dba Game Ready). The 510(k) number is K192114.
When was Game Ready GRPro 2.1 System approved by the FDA?
Game Ready GRPro 2.1 System received FDA 510(k) clearance on 2019-10-29, under approval number K192114.
What company makes Game Ready GRPro 2.1 System?
Game Ready GRPro 2.1 System is manufactured by Cool Systems, Inc. (Dba Game Ready).
What is the FDA product code for Game Ready GRPro 2.1 System?
The FDA product code for Game Ready GRPro 2.1 System is IRP.
Related Clinical Trials
Other Devices by Cool Systems, Inc. (Dba Game Ready)
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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.