The following data is part of a premarket notification filed by Oxygen Enrichment Company, Ltd. with the FDA for Oeco Membrane Oxygne & Vapor Enricher Model Oe-8.
| Device ID | K880044 |
| 510k Number | K880044 |
| Device Name: | OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8 |
| Classification | Generator, Oxygen, Portable |
| Applicant | OXYGEN ENRICHMENT COMPANY, LTD. 1900 MAXON RD. P.O. BOX 1025 Schenectady, NY 12308 |
| Contact | James C Hussey |
| Correspondent | James C Hussey OXYGEN ENRICHMENT COMPANY, LTD. 1900 MAXON RD. P.O. BOX 1025 Schenectady, NY 12308 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-06 |
| Decision Date | 1988-03-28 |