| K-number | K132287 |
| Device name | JAZZ SYSTEM |
| Applicant | Hogan Lovells US LLP |
| Product code | OWI |
| Device class | Class II |
| Decision date | Sep 25, 2013 |
| Decision | Substantially Equivalent |
| Regulation | 888.3010 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov