510(k) K131897 ยท MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
CV3000 HOLTER ANALYSIS SYSTEM
| Applicant | Vales & Hills Biomedical Tech. , Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Nov 26, 2013 |
| Received | Jun 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131897
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.