510(k) K001091 ยท DXH Transmitters And Receivers, Electrocardiograph, Telephone
CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01
| Applicant | Next Millennium Software Solutions, Inc., Hialeah FL, US |
| Decision | Substantially Equivalent, Aug 10, 2000 |
| Received | Apr 4, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001091
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.