The following data is part of a premarket notification filed by Pacific Precision Products with the FDA for O2pak Oxygen Generator.
| Device ID | K120566 |
| 510k Number | K120566 |
| Device Name: | O2PAK OXYGEN GENERATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | PACIFIC PRECISION PRODUCTS 9671 IRVINE CENTER DRIVE Irvine, CA 92618 |
| Contact | Gerald White |
| Correspondent | Gerald White PACIFIC PRECISION PRODUCTS 9671 IRVINE CENTER DRIVE Irvine, CA 92618 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-27 |
| Decision Date | 2012-07-24 |
| Summary: | summary |