Game Ready GRPro 2.1 System
FDA 510(k) clearance K192114 · decided 2019-10-29
Clearance details
- K-number
- K192114
- Device name
- Game Ready GRPro 2.1 System
- Applicant
- Cool Systems, Inc. (Dba Game Ready)
- Decision
- Substantially Equivalent
- Date received
- 2019-08-06
- Decision date
- 2019-10-29
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- IRP
- Device class
- 2
- Regulation number
- 890.5650
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Concord, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.