COPD LIQUID OXYGEN PORTABLE, MODEL 300P

Unit, Liquid-oxygen, Portable

COPD PARTNERS, INC.

The following data is part of a premarket notification filed by Copd Partners, Inc. with the FDA for Copd Liquid Oxygen Portable, Model 300p.

Pre-market Notification Details

Device IDK072011
510k NumberK072011
Device Name:COPD LIQUID OXYGEN PORTABLE, MODEL 300P
ClassificationUnit, Liquid-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 CodeBYJ  
CFR Regulation Number868.5655 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-23
Decision Date2007-10-18
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.