The following data is part of a premarket notification filed by Copd Partners, Inc. with the FDA for Model 300d Home Oxygen Liquefier.
Device ID | K071461 |
510k Number | K071461 |
Device Name: | MODEL 300D HOME OXYGEN LIQUEFIER |
Classification | Generator, 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 | CAW |
CFR Regulation Number | 868.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-05-25 |
Decision Date | 2007-08-21 |
Summary: | summary |