510(k) K101273 ยท MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
DYNAMIC ECG SYSTEM MODEL TLC5000
| Applicant | Contec Medical System Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Sep 30, 2011 |
| Received | May 6, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101273
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.