510(k) K053378 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
LOOP RECORDER VITAPHONE, 3100 SERIES
| Applicant | Tms Telemedizinische Systeme GmbH, Chemnitz, DE |
| Decision | Substantially Equivalent, Feb 23, 2006 |
| Received | Dec 5, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053378
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.