The following data is part of a premarket notification filed by Essex Industries, Inc. with the FDA for Mass Oxygen Distribution System (mods) Model 10c-0061-3.
| Device ID | K101272 |
| 510k Number | K101272 |
| Device Name: | MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 |
| Classification | Unit, Liquid-oxygen, Portable |
| Applicant | ESSEX INDUSTRIES, INC. 8007 CHIVVIS DRIVE St. Louis, MO 63123 |
| Contact | Ken Seise |
| Correspondent | Ken Seise ESSEX INDUSTRIES, INC. 8007 CHIVVIS DRIVE 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 | 2010-05-06 |
| Decision Date | 2010-08-20 |
| Summary: | summary |