| Device Type ID | 2206 |
| Device Name | System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MEQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2206 |
| Device | System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy |
| Product Code | MEQ |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Temperature Sensor | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Catheter | 1 |
| Total Device Problems | 3 |