Epcom Medical Systems, Inc.
Medical device manufacturer in Livermore, CA.
13510(k) clearances
0PMA approvals
0recalls
Device types
- HGM System, Monitoring, Perinatal 4
- IYO System, Imaging, Pulsed Echo, Ultrasonic 1
- HHI System, Abortion, Vacuum 1
- KNG Monitor, Ultrasonic, Fetal 1
- FAP Cystometric Gas (Carbon-Dioxide) On… 1
- FFG Device, Urine Flow Rate Measuring… 1
- HGP Electrode, Circular (Spiral), Scalp And… 1
- HDR Cap, Cervical 1
- HGS Catheter, Intrauterine And Introducer 1
- HGE Amniotome 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K910518 | Glove-N-Gel Amniotomy KitHGE · Traditional | 05/09/1991SESK |
| K905812 | Intrauterine Catheter SetHGS · Traditional | 01/31/1991SE |
| K881414 | CervicathHDR · Traditional | 06/14/1988SE |
| K871079 | Fetalflex Fetal ElectrodeHGP · Traditional | 07/13/1987SE |
| K844338 | 1URO-LOG Home Diagnostic PackFFG · Traditional | 02/25/1985SE |
| K844503 | Urostresstik Diagnostic Cystometry PackFAP · Traditional | 01/02/1985SE |
| K841805 | Obstetrical DopplerKNG · Traditional | 06/19/1984SE |
| K831115 | Epcom EMS-320 Remote MonitorscopeHGM · Traditional | 08/12/1983SE |
| K831114 | Epcom EMS-330 Freedom I Teledop ObstetHGM · Traditional | 08/12/1983SE |
| K831113 | Epcom EMS-310 Intrapartum MonitorHGM · Traditional | 08/12/1983SE |
| K831112 | Epcom VCU-1 Vacuum System & CuretteHHI · Traditional | 06/30/1983SE |
| K813275 | Epcom EMS Scan IIIYO · Traditional | 03/31/1982SE |
| K813007 | Epcom EMS-180 Antepartum Fetal MonitorHGM · Traditional | 12/10/1981SE |