The following data is part of a premarket notification filed by Essex Cryogenics Of Missouri, Inc. with the FDA for Oxygen Generator Liquefier - (ogl).
| Device ID | K131990 |
| 510k Number | K131990 |
| Device Name: | OXYGEN GENERATOR LIQUEFIER - (OGL) |
| Classification | Generator, Oxygen, Portable |
| Applicant | ESSEX CRYOGENICS OF MISSOURI, INC. 8007 CHIVVIS DR. St. Louis, MO 63123 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-28 |
| Decision Date | 2014-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815363020018 | K131990 | 000 |
| 10815363020001 | K131990 | 000 |