REMSTAR AUTO WITH C-FLEX 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 Remstar Auto With C-flex Cpap System.

Pre-market Notification Details

Device IDK041010
510k NumberK041010
Device Name:REMSTAR AUTO WITH C-FLEX CPAP SYSTEM
ClassificationVentilator, Non-continuous (respirator)
Applicant RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville,  PA  15668
ContactZita A Yurko
CorrespondentZita A Yurko
RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville,  PA  15668
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-20
Decision Date2004-05-05
Summary:summary

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