Med4 Elite— 510(k) K171685
Substantially EquivalentCool 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). Device class: 2.
Clearance details
- Applicant
- Cool Systems, Inc. (Dba Game Ready)
- Product code
- Code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Concord, CA, US
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