510(k) K992197 ยท MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
MODIFICATION TO ZYMED HOLTER 2000
| Applicant | Zymed Medical Instrumentation, Camarillo CA, US |
| Decision | Substantially Equivalent, Jul 28, 1999 |
| Received | Jun 30, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K992197
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.