Definition: Call For PMAs To Be Filed By 10/3/00 Per 65 FR 41332 On 7/5/00
| Device Type ID | 3913 |
| Device Name | Analyzer, Data, Obstetric |
| Regulation Description | Obstetric Data Analyzer. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | PMA |
| CFR Regulation Number | 884.2050 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | HEO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3913 |
| Device | Analyzer, Data, Obstetric |
| Product Code | HEO |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Obstetric Data Analyzer. |
| CFR Regulation Number | 884.2050 [🔎] |