DEVILBISS INTELLIPAP MODEL DV 5 SERIES

Ventilator, Non-continuous (respirator)

SUNRISE MEDICAL

The following data is part of a premarket notification filed by Sunrise Medical with the FDA for Devilbiss Intellipap Model Dv 5 Series.

Pre-market Notification Details

Device IDK071689
510k NumberK071689
Device Name:DEVILBISS INTELLIPAP MODEL DV 5 SERIES
ClassificationVentilator, Non-continuous (respirator)
Applicant SUNRISE MEDICAL 100 DEVILBISS DR. Somerset,  PA  15501
ContactJoseph E Olsavsky
CorrespondentJoseph E Olsavsky
SUNRISE MEDICAL 100 DEVILBISS DR. Somerset,  PA  15501
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-06-20
Decision Date2007-09-07

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