STARDUST II

Ventilatory Effort Recorder

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Stardust Ii.

Pre-market Notification Details

Device IDK052573
510k NumberK052573
Device Name:STARDUST II
ClassificationVentilatory Effort Recorder
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 CodeMNR  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-09-19
Decision Date2005-12-13
Summary:summary

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