MODEL DELTA, OM OXYGEN CONCENTRATOR

Generator, Oxygen, Portable

CAIRE, INC.

The following data is part of a premarket notification filed by Caire, Inc. with the FDA for Model Delta, Om Oxygen Concentrator.

Pre-market Notification Details

Device IDK952268
510k NumberK952268
Device Name:MODEL DELTA, OM OXYGEN CONCENTRATOR
ClassificationGenerator, Oxygen, Portable
Applicant CAIRE, INC. 10488 WEST CENTENNIAL RD. Littleton,  CO  80127
ContactLinda Chjapman
CorrespondentLinda Chjapman
CAIRE, INC. 10488 WEST CENTENNIAL RD. Littleton,  CO  80127
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-15
Decision Date1995-08-11

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