PUREtrace™

Uterine Electromyographic Monitor

NEMO HEALTHCARE BV

The following data is part of a premarket notification filed by Nemo Healthcare Bv with the FDA for Puretrace™.

Pre-market Notification Details

Device IDK153262
510k NumberK153262
Device Name:PUREtrace™
ClassificationUterine Electromyographic Monitor
Applicant NEMO HEALTHCARE BV De Run 4630 5504 DB Veldhoven,  NL
ContactAron Wierts
CorrespondentAron Wierts
NEMO HEALTHCARE BV De Run 4630 5504 DB Veldhoven,  NL
Product CodeOSP  
CFR Regulation Number884.2720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-10
Decision Date2017-02-07
Summary:summary

Trademark Results [PUREtrace]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PURETRACE
PURETRACE
86973038 5408116 Live/Registered
Authenticity Assurance LLC
2016-04-12
PURETRACE
PURETRACE
86973013 5408115 Live/Registered
Authenticity Assurance LLC
2016-04-12
PURETRACE
PURETRACE
86973000 5408113 Live/Registered
Authenticity Assurance LLC
2016-04-12
PURETRACE
PURETRACE
85306791 not registered Dead/Abandoned
Micron Products, Inc.
2011-04-28
PURETRACE
PURETRACE
79109625 4482943 Live/Registered
Nemo Healthcare B.V.
2011-12-20
PURETRACE
PURETRACE
78360332 2920907 Dead/Cancelled
Sophos Plc
2004-01-30
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