| K-number | K021502 |
| Device name | OSCAR, MODEL OE3000 |
| Applicant | Orthosonics, Ltd. |
| Product code | LZV |
| Device class | Class II |
| Decision date | Jun 6, 2002 |
| Decision | Substantially Equivalent |
| Regulation | 888.4580 |
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