The following data is part of a premarket notification filed by Essex Cryogenics Of Missouri, Inc. with the FDA for Next Generation Portable Therapeutic Liquid Oxygen System.
| Device ID | K033000 |
| 510k Number | K033000 |
| Device Name: | NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM |
| Classification | Unit, Liquid-oxygen, Portable |
| Applicant | ESSEX CRYOGENICS OF MISSOURI, INC. 8007 CHIVVIS DR. St. Louis, MO 63123 |
| Contact | Elizabeth Hunnicutt |
| Correspondent | Elizabeth Hunnicutt ESSEX CRYOGENICS OF MISSOURI, INC. 8007 CHIVVIS DR. St. Louis, MO 63123 |
| Product Code | BYJ |
| CFR Regulation Number | 868.5655 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-25 |
| Decision Date | 2004-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815363020032 | K033000 | 000 |