Cleared Traditional

EUM 100PRO

K131889 · Promedic, Inc. · Obstetrics & Gynecology
Apr 2014
Decision
302d
Days
Class 2
Risk

About This 510(k) Submission

K131889 is an FDA 510(k) clearance for the EUM 100PRO, a Uterine Electromyographic Monitor (Class II — Special Controls, product code OSP), submitted by Promedic, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on April 23, 2014, 302 days after receiving the submission on June 25, 2013. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.2720.

Submission Details

510(k) Number K131889 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2013
Decision Date April 23, 2014
Days to Decision 302 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code OSP — Uterine Electromyographic Monitor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.2720
Definition The Uterine Electromyographic Monitor Is Intended To Pick Up Uterine Emg Signals From Surface Electrodes Placed On The Maternal Abdomen. It Produces A Uterine Activity Tracing And Monitors Women In Labor At Term Gestation With A Singleton Pregnancy.