Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K171685
Med4 Elite · Cool Systems, Inc. (Dba Game Ready) · decided 2017-09-29 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Game Ready Med4 Elite Therapy Hose Assembly - Patient 1 | 503647 | Avanos Medical, Inc. | ILO IRP | 00812120004031 |
| Game Ready Med4 Accessory Kit | 303945-FR01 | Avanos Medical, Inc. | ILO IRP | 00812120003744 |
| Game Ready Med4 Accessory Kit | 303945-FR06 | Avanos Medical, Inc. | ILO IRP | 00812120003768 |
| Game Ready Med4 Elite Therapy Hose Assembly - Patient 2 | 503648 | Avanos Medical, Inc. | ILO IRP | 00812120004048 |
| Med4Elite Accessories | 303945-FR06 | Avanos Medical, Inc. | ILO IRP | 00812120004413 |
| GAME READY* Med4 Elite* Accessory Kit | 303945-EN03 | Avanos Medical, Inc. | ILO IRP | 00812120004260 |
| Game Ready Med4 Accessory Kit | 303945-EN10 | Avanos Medical, Inc. | ILO IRP | 00812120003669 |
| Game Ready Med4 Accessory Kit | 303945-PB07 | Avanos Medical, Inc. | ILO IRP | 00812120003805 |
| GAME READY* Med4 Elite* Accessory Kit | 303945-EN06 | Avanos Medical, Inc. | ILO IRP | 00812120004284 |
| Game Ready Med4 Accessory Kit | 303945-EX08 | Avanos Medical, Inc. | ILO IRP | 00812120003737 |
| Game Ready Med4 Accessory Kit | 303945-EN11 | Avanos Medical, Inc. | ILO IRP | 00812120003676 |
| Game Ready Med4 Accessory Kit | 303945-EN13 | Avanos Medical, Inc. | ILO IRP | 00812120003683 |
| Game Ready Med4 Accessory Kit | 303945-EN03 | Avanos Medical, Inc. | ILO IRP | 00812120003614 |
| GAME READY* Med4 Elite* Accessory Kit | 303945-EN13 | Avanos Medical, Inc. | ILO IRP | 00812120004338 |
| Game Ready Med4 Accessory Kit | 303945-EN01 | Avanos Medical, Inc. | ILO IRP | 00812120003591 |
| GAME READY* Med4 Elite* Accessory Kit | 303945-EX08 | Avanos Medical, Inc. | ILO IRP | 00812120004383 |
| GAME READY* MED4 Elite* Control Unit | 650500 | Avanos Medical, Inc. | ILO IRP | 00812120004208 |
| Game Ready Med4 Accessory Kit | 303945-EN07 | Avanos Medical, Inc. | ILO IRP | 00812120003645 |
| GAME READY* Med4 Elite* Accessory Kit | 303945-PB07 | Avanos Medical, Inc. | ILO IRP | 00812120004451 |
| Med4 Elite | 650550-LN | Avanos Medical, Inc. | ILO IRP | 00812120003188 |
| Med4Elite Accessories | 303945-EN01 | Avanos Medical, Inc. | ILO IRP | 00812120004246 |
| GAME READY* Med4 Elite* Accessory Kit | 303945-EX01 | Avanos Medical, Inc. | ILO IRP | 00812120004352 |
| GAME READY* Med4 Elite* Accessory Kit | 303945-EN14 | Avanos Medical, Inc. | ILO IRP | 00812120004345 |
| Game Ready Med4 Elite Drain Hose | 573240 | Avanos Medical, Inc. | ILO IRP | 00812120002662 |
| Game Ready Med4 Accessory Kit | 303945-EX01 | Avanos Medical, Inc. | ILO IRP | 00812120003706 |