The following data is part of a premarket notification filed by Copd Partners, Inc. with the FDA for Copd Liquid Oxygen Portable, Model 300p.
Device ID | K072011 |
510k Number | K072011 |
Device Name: | COPD LIQUID OXYGEN PORTABLE, MODEL 300P |
Classification | Unit, Liquid-oxygen, Portable |
Applicant | COPD PARTNERS, INC. 3460 POINTE CREEK CT. SUITE 102 Bonita Springs, FL 34134 -2015 |
Contact | Paul Dryden |
Correspondent | Paul Dryden COPD PARTNERS, INC. 3460 POINTE CREEK CT. SUITE 102 Bonita Springs, FL 34134 -2015 |
Product Code | BYJ |
CFR Regulation Number | 868.5655 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-23 |
Decision Date | 2007-10-18 |
Summary: | summary |