Definition: The Uterine Electromyographic Monitor Is Intended To Pick Up Uterine Emg Signals From Surface Electrodes Placed On The Maternal Abdomen. It Produces A Uterine Activity Tracing And Monitors Women In Labor At Term Gestation With A Singleton Pregnancy.
| Device Type ID | 4071 |
| Device Name | Uterine Electromyographic Monitor |
| Physical State | Monitor With Associated Electronics And Patient Skin Electrodes. |
| Technical Method | Abdominal EMG Surface Electrodes That Pick Up Electrical Activity From The Uterus In Labor, Electrical Signal Converted To A Monitor Tracing. |
| Target Area | Maternal Abdomen And Uterus |
| Regulation Description | External Uterine Contraction Monitor And Accessories. |
| 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 | 510(k) |
| CFR Regulation Number | 884.2720 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OSP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4071 |
| Device | Uterine Electromyographic Monitor |
| Product Code | OSP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | External Uterine Contraction Monitor And Accessories. |
| CFR Regulation Number | 884.2720 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MONICA HEALTHCARE LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OBMEDICAL COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PROMEDIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | GE Healthcare, LLC | II | Mar-14-2018 |
| 2 | MONICA HEALTHCARE LTD | II | May-25-2017 |