| K-number | K832745 |
| Device name | OC3 FLYER |
| Applicant | Intl. Medical Equipment Corp. |
| Product code | ITI |
| Device class | Class II |
| Decision date | Sep 20, 1983 |
| Decision | Substantially Equivalent |
| Regulation | 890.3860 |
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