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FDA 510(k)

Game Ready GRPro 2.1 System

K-Number: K192114 · 2019-10-29

Decision Date2019-10-29
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Game Ready GRPro 2.1 System is the device name listed in this FDA 510(k) record. The listed applicant is Cool Systems, Inc. (Dba Game Ready). It received FDA 510(k) clearance on 2019-10-29 under 510(k) 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. The listed applicant is Cool Systems, Inc. (Dba Game Ready). The 510(k) number is K192114.

When did Game Ready GRPro 2.1 System receive FDA 510(k) clearance?

Game Ready GRPro 2.1 System received FDA 510(k) clearance on 2019-10-29, under 510(k) number K192114.

Who is the listed applicant for Game Ready GRPro 2.1 System?

The FDA 510(k) record lists Cool Systems, Inc. (Dba Game Ready) as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Cool Systems, Inc. (Dba Game Ready) 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.

Related Devices (Code: IRP)

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.

Official Source

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