The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Precision Liquid Oxygen System.
| Device ID | K041122 |
| 510k Number | K041122 |
| Device Name: | PRECISION LIQUID OXYGEN SYSTEM |
| Classification | Unit, Liquid-oxygen, Portable |
| Applicant | PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
| Contact | James Parker |
| Correspondent | James Parker PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
| Product Code | BYJ |
| CFR Regulation Number | 868.5655 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-29 |
| Decision Date | 2004-10-04 |
| Summary: | summary |