The following data is part of a premarket notification filed by Miti Corp. with the FDA for Accu02 System.
| Device ID | K051007 |
| 510k Number | K051007 |
| Device Name: | ACCU02 SYSTEM |
| Classification | Conserver, Oxygen |
| Applicant | MITI CORP. 555 13TH STREET, NW Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan MITI CORP. 555 13TH STREET, NW Washington, DC 20004 -1109 |
| Product Code | NFB |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-20 |
| Decision Date | 2005-06-16 |
| Summary: | summary |