The following data is part of a premarket notification filed by Essex Cryogenics Of Missouri, Inc. with the FDA for Backpack Medical Oxygen System.
| Device ID | K071581 |
| 510k Number | K071581 |
| Device Name: | BACKPACK MEDICAL OXYGEN SYSTEM |
| Classification | Unit, Liquid-oxygen, Portable |
| Applicant | ESSEX CRYOGENICS OF MISSOURI, INC. 8007 CHIVVIS DR. St. Louis, MO 63123 |
| Contact | Elizabeth Hunnicutt |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | BYJ |
| CFR Regulation Number | 868.5655 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-06-08 |
| Decision Date | 2007-07-11 |
| Summary: | summary |