Epcom EMS-320 Remote Monitorscope
FDA 510(k) K831115 · Epcom Medical Systems, Inc.
510(k) numberK831115
Submission
- Device name
- Epcom EMS-320 Remote Monitorscope
- Applicant
- Epcom Medical Systems, Inc.
Mchenry, IL, US - Received
- April 5, 1983
- Decision date
- August 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HGM – System, Monitoring, Perinatal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2740
- Specialty
- Obstetrics/Gynecology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254036 | Novii+ Wireless Patch SystemHGM · Traditional | Datex Ohmeda, Inc. | 08/10/2026SE |
| K253021 | ANNE MaternalHGM · Traditional | Sibel Health, Inc. | 02/26/2026SE |
| K250777 | Sonicaid Team3HGM · Traditional | Huntleigh Healthcare , Ltd. | 09/19/2025SE |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air)HGM · Traditional | Edan Instruments, Inc. | 08/27/2025SE |
| K241368 | Sonicaid Team3HGM · Traditional | Huntleigh Healthcare , Ltd. | 02/03/2025SE |
| K241009 | PeriCALM Patterns 3.0HGM · Traditional | Perigen, Inc. | 01/10/2025SE |
| K233440 | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch…HGM · Traditional | Philips Medizin Systeme Boeblingen GmbH | 07/02/2024SE |
| K231964 | Novii+ Wireless Patch SystemHGM · Traditional | Datex Ohmeda | 12/08/2023SE |
| K222327 | Bloomlife MFM-ProHGM · Traditional | Bloom Technologies NV | 02/13/2023SE |
| K220732 | Mural Perinatal SurveillanceHGM · Traditional | Ge Medical Systems Information Technologies, Inc. | 06/23/2022SE |
More from Ge Medical Systems Information Technologies, Inc.
| 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 |
| 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 |
Questions and answers
When was Epcom EMS-320 Remote Monitorscope cleared by the FDA?
Epcom EMS-320 Remote Monitorscope (K831115) received a 510(k) decision of Substantially Equivalent on August 12, 1983, 129 days after the submission was received.
What is the product code of K831115?
The FDA product code is HGM – System, Monitoring, Perinatal, a Class II (moderate risk) device regulated under 21 CFR 884.2740.