Cambridge Heart, Inc. · Class II · Cleared Jan 18, 2001
| K-number | K003492 |
| Device name | ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS |
| Applicant | Cambridge Heart, Inc. |
| Product code | DQK |
| Device class | Class II |
| Decision date | Jan 18, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 870.1425 |
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