510(k) K010756 ยท DQK Computer, Diagnostic, Programmable
CH 2000 CARDIAC DIAGNOSTIC SYSTEM
| Applicant | Cambridge Heart, Inc., South West Ranches FL, US |
| Decision | Substantially Equivalent, Apr 12, 2001 |
| Received | Mar 13, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010756
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.