The following data is part of a premarket notification filed by Pacific Consolidated Industries Llp with the FDA for Deployable Oxygen Concentration System (docs).
| Device ID | K020330 |
| 510k Number | K020330 |
| Device Name: | DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS) |
| Classification | Generator, Oxygen, Portable |
| Applicant | PACIFIC CONSOLIDATED INDUSTRIES LLP 3430 WEST CARRIAGE DR. Santa Ana, CA 92704 |
| Contact | Lee W Smith |
| Correspondent | Lee W Smith PACIFIC CONSOLIDATED INDUSTRIES LLP 3430 WEST CARRIAGE DR. Santa Ana, CA 92704 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-31 |
| Decision Date | 2002-04-12 |
| Summary: | summary |