510(k) K100362 ยท DQK Computer, Diagnostic, Programmable
CAMBRIDGE HEART OEM
| Applicant | Cambridge Heart, Inc., South West Ranches FL, US |
| Decision | Substantially Equivalent, Apr 14, 2010 |
| Received | Feb 12, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100362
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.