Med4 Elite
K-Number: K171685 · 2017-09-29
Device Summary
Frequently Asked Questions
What is the Med4 Elite?
Med4 Elite is a medical device that received FDA 510(k) clearance on 2017-09-29. The listed applicant is Cool Systems, Inc. (Dba Game Ready). The 510(k) number is K171685.
When did Med4 Elite receive FDA 510(k) clearance?
Med4 Elite received FDA 510(k) clearance on 2017-09-29, under 510(k) number K171685.
Who is the listed applicant for Med4 Elite?
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 Med4 Elite?
The FDA product code for Med4 Elite 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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.