| K-number | K851669 |
| Device name | MONITOR IV PLUS |
| Applicant | Helena Laboratories |
| Product code | JOZ |
| Device class | Class II |
| Decision date | Jul 23, 1985 |
| Decision | Substantially Equivalent |
| Regulation | 864.5700 |
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