PUREtrace™

FDA 510(k) K153262 · Nemo Healthcare BV

Substantially Equivalent

510(k) numberK153262

Submission

Device name
PUREtrace™
Applicant
Nemo Healthcare BV
Veldhoven, NL
Received
November 10, 2015
Decision date
February 7, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OSP – Uterine Electromyographic Monitor
Device class
Class II (moderate risk)
Regulation
21 CFR 884.2720
Specialty
Obstetrics/Gynecology

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.

Other 510(k)s with product code OSP

510(k)DeviceApplicantDecision
K190798LaborView™ LV1000 Wireless Electrode SystemOSP · Traditional Obmedical Company09/18/2020SE
K142583LaborView LV1000OSP · Traditional Obmedical Company01/16/2015SE
K140862Monica Novii Wireless Patch SystemOSP · Traditional Monica Healthcare, Ltd.08/27/2014SE
K131889Eum 100PROOSP · Traditional Promedic, Inc.04/23/2014SE
K130002Surecall Labor MonitorOSP · Traditional Reproductive Research Technologies, LP06/28/2013SE
K112390Monica AN24OSP · Traditional Monica Healthcare, Ltd.07/13/2012SE
K112163Monica IF24OSP · Traditional Monica Healthcare08/30/2011SE
K101801Monica AN24OSP · Traditional Monica Healthcare02/03/2011SE
K090145Surecall Emg Labor MonitorOSP · Traditional Reproductive Research Technologies, LP01/25/2011SE

Questions and answers

When was PUREtrace™ cleared by the FDA?

PUREtrace™ (K153262) received a 510(k) decision of Substantially Equivalent on February 7, 2017, 455 days after the submission was received.

What is the product code of K153262?

The FDA product code is OSP – Uterine Electromyographic Monitor, a Class II (moderate risk) device regulated under 21 CFR 884.2720.