| Device |
monitor, electroencephalographic, fetal (and accessories) |
| Regulation Description |
Fetal electroencephalographic monitor. |
| Definition |
Call for pmas to be filed by 12/26/96 per 61 fr 50708 on 9/27/96. |
| Regulation Medical Specialty |
Obstetrics/Gynecology |
| Review Panel |
Obstetrics/Gynecology |
| Product Code | HGO |
| Submission Type |
PMA
|
| Regulation Number |
884.2620
|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|