| K-number | K833009 |
| Device name | OMNI-FAL I & II |
| Applicant | American Monitor Corp. |
| Product code | JJY |
| Device class | Class I |
| Decision date | Jan 13, 1984 |
| Decision | Substantially Equivalent |
| Regulation | 862.1660 |
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