The following data is part of a premarket notification filed by Essex Industries, Inc. D/b/a Essex Cryogenics Of M with the FDA for Dismounted Medical & Supplemental Oxygen System (dmos).
| Device ID | K130068 |
| 510k Number | K130068 |
| Device Name: | DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) |
| Classification | Unit, Liquid-oxygen, Portable |
| Applicant | ESSEX INDUSTRIES, INC. D/B/A ESSEX CRYOGENICS OF M 8007 CHIVVIS DRIVE St. Louis, MO 63123 -2395 |
| Contact | Ken Seise |
| Correspondent | Ken Seise ESSEX INDUSTRIES, INC. D/B/A ESSEX CRYOGENICS OF M 8007 CHIVVIS DRIVE St. Louis, MO 63123 -2395 |
| Product Code | BYJ |
| CFR Regulation Number | 868.5655 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-11 |
| Decision Date | 2013-07-19 |
| Summary: | summary |