Ge Medical Systems Information Technologies · Class II · Cleared Feb 24, 2010
| K-number | K092369 |
| Device name | 12SL ECG ANALYSIS PROGRAM |
| Applicant | Ge Medical Systems Information Technologies |
| Product code | MHX |
| Device class | Class II |
| Decision date | Feb 24, 2010 |
| 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