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Epcom Medical Systems, Inc.

United StatesFDA applicant, unverified

Devices
13

What Epcom Medical Systems, Inc. makes

Epcom Medical Systems, Inc. manufactures medical devices for obstetric, urological, and fetal monitoring applications, including intrapartum and antepartum fetal heart rate monitors, amniotomy kits, intrauterine catheter sets, and diagnostic cystometry packs for bladder function assessment. The company also produces remote monitoring systems for obstetric care, vacuum extraction systems for childbirth assistance, and home diagnostic packs for urinary function testing. Additional offerings include fetal electrodes for continuous monitoring and a vacuum-assisted delivery system with curette attachment.

The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) database. Products are intended for use in the United States, where compliance with FDA requirements applies. No additional international registries or classifications are specified.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue13

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  • Cervicath Ref K881414

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Urostresstik Diagnostic Cystometry Pack Ref K844503

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Epcom Ems-310 Intrapartum Monitor Ref K831113

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Glove-N-Gel Amniotomy Kit Ref K910518

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Epcom Ems-180 Antepartum Fetal Monitor Ref K813007

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Intrauterine Catheter Set Ref K905812

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Epcom Ems-330 Freedom I Teledop Obstet Ref K831114

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Epcom Ems Scan Ii Ref K813275

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • 1URO-Log Home Diagnostic Pack Ref K844338

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Epcom Ems-320 Remote Monitorscope Ref K831115

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Epcom Vcu-1 Vacuum System & Curette Ref K831112

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Fetalflex Fetal Electrode Ref K871079

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Obstetrical Doppler Ref K841805

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-13 of 13

Frequently asked questions

How many devices does Epcom Medical Systems, Inc. have in the registry?

The registry currently lists 13 devices for Epcom Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Epcom Medical Systems, Inc.'s devices?

Among its 13 most recently registered devices, Epcom Medical Systems, Inc. has devices listed in FDA 510(k) (13 devices).

What risk classes do Epcom Medical Systems, Inc.'s devices fall under?

Among its 13 most recently registered devices, the classes recorded for Epcom Medical Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Epcom Medical Systems, Inc. in the registry?

The most recently registered devices listed for Epcom Medical Systems, Inc. include CERVICATH, UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK, EPCOM EMS-310 INTRAPARTUM MONITOR and GLOVE-N-GEL AMNIOTOMY KIT.

Generated automatically from registry data and not verified by a human reviewer.