| K-number | K080348 |
| Device name | OXISCAN II DATA MANAGEMENT SYSTEM |
| Applicant | Airsep Corp. |
| Product code | DQA |
| Device class | Class II |
| Decision date | Oct 9, 2008 |
| Decision | Substantially Equivalent |
| Regulation | 870.2700 |
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View the full FDA submission: accessdata.fda.gov