Edan Instruments, Inc. · Class II · Cleared Jul 24, 2009
| K-number | K091513 |
| Device name | SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200 |
| Applicant | Edan Instruments, Inc. |
| Product code | DPS |
| Device class | Class II |
| Decision date | Jul 24, 2009 |
| Decision | Substantially Equivalent |
| Regulation | 870.2340 |
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