The following data is part of a premarket notification filed by Molecular Products Ltd. with the FDA for Portable Oxygen Generator System.
| Device ID | K062153 |
| 510k Number | K062153 |
| Device Name: | PORTABLE OXYGEN GENERATOR SYSTEM |
| Classification | Generator, Oxygen, Portable |
| Applicant | MOLECULAR PRODUCTS LTD. 3460 POINTE CREEK CT. # 102 Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden MOLECULAR PRODUCTS LTD. 3460 POINTE CREEK CT. # 102 Bonita Springs, FL 34134 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-27 |
| Decision Date | 2006-11-21 |
| Summary: | summary |