Med4 Elite— 510(k) K171685

Substantially Equivalent

Cool Systems, Inc. (Dba Game Ready)

FDA 510(k) clearance K171685 for Med4 Elite, Substantially Equivalent on 2017-09-29. Applicant: Cool Systems, Inc. (Dba Game Ready).

Clearance details

Applicant
Cool Systems, Inc. (Dba Game Ready)
Product code
Code IRP
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Concord, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.