| K-number | K113653 |
| Device name | PATIENT MONITOR |
| Applicant | Edan Instruments, Inc. |
| Product code | MHX |
| Device class | Class II |
| Decision date | Feb 6, 2012 |
| Decision | Substantially Equivalent |
| Regulation | 870.1025 |
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