Cleared Traditional

K140862 - MONICA NOVII WIRELESS PATCH SYSTEM
(FDA 510(k) Clearance)

K140862 · Monica Healthcare, Ltd. · Obstetrics & Gynecology
Aug 2014
Decision
146d
Days
Class 2
Risk

K140862 is an FDA 510(k) clearance for the MONICA NOVII WIRELESS PATCH SYSTEM. This device is classified as a Uterine Electromyographic Monitor (Class II — Special Controls, product code OSP).

Submitted by Monica Healthcare, Ltd. (Nottingham, GB). The FDA issued a Cleared decision on August 27, 2014, 146 days after receiving the submission on April 3, 2014.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2720. 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..

Submission Details

510(k) Number K140862 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2014
Decision Date August 27, 2014
Days to Decision 146 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.