DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE)

Conserver, Oxygen

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 1400d (oxygen Conserving Device).

Pre-market Notification Details

Device IDK890141
510k NumberK890141
Device Name:DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE)
ClassificationConserver, Oxygen
Applicant DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset,  PA  15501 -0635
ContactDavid Gast
CorrespondentDavid Gast
DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset,  PA  15501 -0635
Product CodeNFB  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-01-13
Decision Date1989-04-06

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