510(k) K842462 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
HOLTER SCREENING MONITOR HS-221
| Applicant | Advantage Medical Systems, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Sep 11, 1984 |
| Received | Jun 22, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K842462
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.