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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Uterine Electromyographic Monitor
510(k) Number K153262
Device Name PUREtrace™
Applicant
Nemo Healthcare BV
De Run 4630
Veldhoven,  NL 5504 DB
Applicant Contact Aron Wierts
Correspondent
Nemo Healthcare BV
De Run 4630
Veldhoven,  NL 5504 DB
Correspondent Contact Aron Wierts
Regulation Number884.2720
Classification Product Code
OSP  
Date Received11/10/2015
Decision Date 02/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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