| Device |
accessories, germicide, cleaning, for endoscopes |
| Regulation Description |
Endoscope and accessories. |
| Definition |
High level disinfection of reusable, heat-sensitive devices. |
| Physical State |
High level disinfection of reusable, heat-sensitive devices |
| Technical Method |
High level disinfection of reusable, heat-sensitive devices |
| Target Area |
High level disinfection of reusable, heat-sensitive devices |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | NZA |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.1500
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
