MODEL 300D HOME OXYGEN LIQUEFIER

Generator, Oxygen, Portable

COPD PARTNERS, INC.

The following data is part of a premarket notification filed by Copd Partners, Inc. with the FDA for Model 300d Home Oxygen Liquefier.

Pre-market Notification Details

Device IDK071461
510k NumberK071461
Device Name:MODEL 300D HOME OXYGEN LIQUEFIER
ClassificationGenerator, Oxygen, Portable
Applicant COPD PARTNERS, INC. 3460 POINTE CREEK CT. SUITE 102 Bonita Springs,  FL  34134 -2015
ContactPaul Dryden
CorrespondentPaul Dryden
COPD PARTNERS, INC. 3460 POINTE CREEK CT. SUITE 102 Bonita Springs,  FL  34134 -2015
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-25
Decision Date2007-08-21
Summary:summary

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