The following data is part of a premarket notification filed by Aga-linde Health Care with the FDA for Medicyl-e-lite Portable Oxygen Delivery System.
| Device ID | K033897 |
| 510k Number | K033897 |
| Device Name: | MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM |
| Classification | Cylinder, Compressed Gas, And Valve |
| Applicant | AGA-LINDE HEALTH CARE P.O. BOX 391117 Solon, OH 44139 |
| Contact | James Jochen Rogers |
| Correspondent | James Jochen Rogers AGA-LINDE HEALTH CARE P.O. BOX 391117 Solon, OH 44139 |
| Product Code | ECX |
| CFR Regulation Number | 868.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-12-16 |
| Decision Date | 2004-07-19 |
| Summary: | summary |