510(k) K911615 ยท DQK Computer, Diagnostic, Programmable
HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300
| Applicant | Diagnostic Monitoring Software, Tustin CA, US |
| Decision | Substantially Equivalent, Jan 8, 1992 |
| Received | Apr 11, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911615
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.