510(k) K063609 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER
| Applicant | Shl Telemedicine International , Ltd., Somerset MA, US |
| Decision | Substantially Equivalent, Sep 12, 2007 |
| Received | Dec 4, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063609
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.