Company ยท US
Epcom Medical Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1991. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HGM | System, Monitoring, Perinatal | 4 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 1 |
| FFG | Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | 1 |
| HDR | Cap, Cervical | 1 |
| HGE | Amniotome | 1 |
| HGP | Electrode, Circular (Spiral), Scalp And Applicator | 1 |
| HGS | Catheter, Intrauterine And Introducer | 1 |
| HHI | System, Abortion, Vacuum | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 |
| KNG | Monitor, Ultrasonic, Fetal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 9, 1991 | K910518 | GLOVE-N-GEL AMNIOTOMY KIT Epcom Medical Systems, Inc. | HGE |
| Jan 31, 1991 | K905812 | INTRAUTERINE CATHETER SET Epcom Medical Systems, Inc. | HGS |
| Jun 14, 1988 | K881414 | CERVICATH Epcom Medical Systems, Inc. | HDR |
| Jul 13, 1987 | K871079 | FETALFLEX FETAL ELECTRODE Epcom Medical Systems, Inc. | HGP |
| Feb 25, 1985 | K844338 | 1URO-LOG HOME DIAGNOSTIC PACK Epcom Medical Systems, Inc. | FFG |
| Jan 2, 1985 | K844503 | UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK Epcom Medical Systems, Inc. | FAP |
| Jun 19, 1984 | K841805 | OBSTETRICAL DOPPLER Epcom Medical Systems, Inc. | KNG |
| Aug 12, 1983 | K831115 | EPCOM EMS-320 REMOTE MONITORSCOPE Epcom Medical Systems, Inc. | HGM |
| Aug 12, 1983 | K831114 | EPCOM EMS-330 FREEDOM I TELEDOP OBSTET Epcom Medical Systems, Inc. | HGM |
| Aug 12, 1983 | K831113 | EPCOM EMS-310 INTRAPARTUM MONITOR Epcom Medical Systems, Inc. | HGM |
| Jun 30, 1983 | K831112 | EPCOM VCU-1 VACUUM SYSTEM & CURETTE Epcom Medical Systems, Inc. | HHI |
| Mar 31, 1982 | K813275 | EPCOM EMS SCAN II Epcom Medical Systems, Inc. | IYO |
| Dec 10, 1981 | K813007 | EPCOM EMS-180 ANTEPARTUM FETAL MONITOR Epcom Medical Systems, Inc. | HGM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||