| Device |
sterilizer automated loading system |
| Regulation Description |
Steam sterilizer. |
| Definition |
Provides automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies.The system consists of a user interface, loading conveyor, load transport shuttles, unloading conveyor to be used as an accessory to a sterilizer. |
| Physical State |
The system consists of a single point user interface station, loading conveyor, load transport shuttles, unloading conveyor and a sterilizer that sits on a loading car. |
| Technical Method |
Works in conjunction with a steam sterilizer |
| Target Area |
NA |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | PEC |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.6880
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
