DEVILBISS MODEL 5000

Nebulizer (direct Patient Interface)

DEVILBISS HEALTH CARE, INC.

The following data is part of a premarket notification filed by Devilbiss Health Care, Inc. with the FDA for Devilbiss Model 5000.

Pre-market Notification Details

Device IDK911896
510k NumberK911896
Device Name:DEVILBISS MODEL 5000
ClassificationNebulizer (direct Patient Interface)
Applicant DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset,  PA  15501 -0635
ContactTerrence M.o`brien
CorrespondentTerrence M.o`brien
DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset,  PA  15501 -0635
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-26
Decision Date1991-07-31

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