RESPIRONICS SLEEPEASY CPAP SYSTEM

Ventilator, Non-continuous (respirator)

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Respironics Sleepeasy Cpap System.

Pre-market Notification Details

Device IDK091112
510k NumberK091112
Device Name:RESPIRONICS SLEEPEASY CPAP SYSTEM
ClassificationVentilator, Non-continuous (respirator)
Applicant RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville,  PA  15146
ContactZita A Yurko
CorrespondentZita A Yurko
RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville,  PA  15146
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-17
Decision Date2009-05-15
Summary:summary

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