| K-number | K140847 |
| Device name | CARDIOSPY ECG HOLTER SYSTEMS |
| Applicant | Labtech Kft. |
| Product code | MLO |
| Device class | Class II |
| Decision date | Dec 5, 2014 |
| Decision | Substantially Equivalent |
| Regulation | 870.2800 |
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