Epcom Medical Systems, Inc.
Walker, MI, US
Epcom Medical Systems, Inc. appears in FDA device records in Walker, MI. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Epcom Medical Systems, Inc. between 1981 and 1991. The busiest year on record is 1983, with 4. The most recent is 1991, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 4 |
| 1984 | 1 |
| 1985 | 2 |
| 1987 | 1 |
| 1988 | 1 |
| 1991 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K910518 | GLOVE-N-GEL AMNIOTOMY KIT | HGE | Unknown | |
| K905812 | INTRAUTERINE CATHETER SET | HGS | Substantially Equivalent | |
| K881414 | CERVICATH | HDR | Substantially Equivalent | |
| K871079 | FETALFLEX FETAL ELECTRODE | HGP | Substantially Equivalent | |
| K844338 | 1URO-LOG HOME DIAGNOSTIC PACK | FFG | Substantially Equivalent | |
| K844503 | UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK | FAP | Substantially Equivalent | |
| K841805 | OBSTETRICAL DOPPLER | KNG | Substantially Equivalent | |
| K831115 | EPCOM EMS-320 REMOTE MONITORSCOPE | HGM | Substantially Equivalent | |
| K831114 | EPCOM EMS-330 FREEDOM I TELEDOP OBSTET | HGM | Substantially Equivalent | |
| K831113 | EPCOM EMS-310 INTRAPARTUM MONITOR | HGM | Substantially Equivalent | |
| K831112 | EPCOM VCU-1 VACUUM SYSTEM & CURETTE | HHI | Substantially Equivalent | |
| K813275 | EPCOM EMS SCAN II | IYO | Substantially Equivalent | |
| K813007 | EPCOM EMS-180 ANTEPARTUM FETAL MONITOR | HGM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- HGEAmniotome
- HDRCap, Cervical
- HGSCatheter, Intrauterine And Introducer
- FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device
- FFGDevice, Urine Flow Rate Measuring, Non-Electrical, Disposable
- HGPElectrode, Circular (Spiral), Scalp And Applicator
- KNGMonitor, Ultrasonic, Fetal
- HHISystem, Abortion, Vacuum
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- HGMSystem, Monitoring, Perinatal
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain