Cleared Traditional

K112390 - MONICA AN24
(FDA 510(k) Clearance)

K112390 · Monica Healthcare, Ltd. · Obstetrics & Gynecology
Jul 2012
Decision
330d
Days
Class 2
Risk

K112390 is an FDA 510(k) clearance for the MONICA AN24, 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 July 13, 2012, 330 days after receiving the submission on August 18, 2011. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.2720.

Submission Details

510(k) Number K112390 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 2011
Decision Date July 13, 2012
Days to Decision 330 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.