SOMNOLYZER 24X7

Ventilatory Effort Recorder

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Somnolyzer 24x7.

Pre-market Notification Details

Device IDK131994
510k NumberK131994
Device Name:SOMNOLYZER 24X7
ClassificationVentilatory Effort Recorder
Applicant RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville,  PA  15146
ContactDaniela Aizpitarte
CorrespondentDaniela Aizpitarte
RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville,  PA  15146
Product CodeMNR  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-28
Decision Date2013-10-17
Summary:summary

Trademark Results [SOMNOLYZER 24X7]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOMNOLYZER 24X7
SOMNOLYZER 24X7
79016696 3211566 Dead/Cancelled
THE SIESTA GROUP SCHLAFANALYSE GMBH
2005-10-05

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