Cambridge Heart, Inc. · Class II · Cleared Aug 18, 2000
| K-number | K002230 |
| Device name | CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 |
| Applicant | Cambridge Heart, Inc. |
| Product code | DRX |
| Device class | Class II |
| Decision date | Aug 18, 2000 |
| Decision | Substantially Equivalent |
| Regulation | 870.2360 |
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