The following data is part of a premarket notification filed by Essex Cryogenics Of Missouri, Inc. with the FDA for Portable Therapeutic Oxygen Concentration System (ptocs).
| Device ID | K022684 |
| 510k Number | K022684 |
| Device Name: | PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS) |
| Classification | Generator, Oxygen, Portable |
| Applicant | ESSEX CRYOGENICS OF MISSOURI, INC. 8007 CHIVVIS DR. St. Louis, MO 63123 |
| Contact | Elizabeth Hunnicut |
| Correspondent | Elizabeth Hunnicut ESSEX CRYOGENICS OF MISSOURI, INC. 8007 CHIVVIS DR. St. Louis, MO 63123 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-12 |
| Decision Date | 2002-09-11 |
| Summary: | summary |