Med4 Elite
K-Number: K171685 · 2017-09-29
ApplicantCool Systems, Inc. (Dba Game Ready)
Decision Date2017-09-29
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Med4 Elite is a medical device manufactured by Cool Systems, Inc. (Dba Game Ready). It received FDA 510(k) clearance on 2017-09-29 under approval number K171685. 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 Med4 Elite?
Med4 Elite is a medical device that received FDA 510(k) clearance on 2017-09-29. It is manufactured by Cool Systems, Inc. (Dba Game Ready). The 510(k) number is K171685.
When was Med4 Elite approved by the FDA?
Med4 Elite received FDA 510(k) clearance on 2017-09-29, under approval number K171685.
What company makes Med4 Elite?
Med4 Elite is manufactured by Cool Systems, Inc. (Dba Game Ready).
What is the FDA product code for Med4 Elite?
The FDA product code for Med4 Elite is IRP.
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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.