BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX

Ventilator, Non-continuous (respirator)

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Bipap Pro 2 Bi-level System With Bi-flex.

Pre-market Notification Details

Device IDK043607
510k NumberK043607
Device Name:BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX
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 Received2004-12-30
Decision Date2005-01-28
Summary:summary

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