MODEL #7354

Ventilator, Non-continuous (respirator)

DEVILBISS HEALTH CARE, INC.

The following data is part of a premarket notification filed by Devilbiss Health Care, Inc. with the FDA for Model #7354.

Pre-market Notification Details

Device IDK950849
510k NumberK950849
Device Name:MODEL #7354
ClassificationVentilator, Non-continuous (respirator)
Applicant DEVILBISS HEALTH CARE, INC. P.O. BOX 635 Somerset,  PA  15501 -0635
ContactMark D'angelo
CorrespondentMark D'angelo
DEVILBISS HEALTH CARE, INC. P.O. BOX 635 Somerset,  PA  15501 -0635
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-24
Decision Date1996-02-08

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