TRILOGY SERIES VENTILATOR WITH OXIMETRY

Ventilator, Continuous, Facility Use

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Trilogy Series Ventilator With Oximetry.

Pre-market Notification Details

Device IDK111610
510k NumberK111610
Device Name:TRILOGY SERIES VENTILATOR WITH OXIMETRY
ClassificationVentilator, Continuous, Facility Use
Applicant RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville,  PA  15146
ContactJoseph E Olsavsky
CorrespondentJoseph E Olsavsky
RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville,  PA  15146
Product CodeCBK  
Subsequent Product CodeDQA
Subsequent Product CodeNOU
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-09
Decision Date2011-10-14
Summary:summary

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