510(k) K863534 ยท DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
LIFE-WATCH MONITOR LT-8
| Applicant | Computerized Medical Systems, Inc., Northbrook IL, US |
| Decision | Substantially Equivalent, Nov 21, 1986 |
| Received | Sep 11, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863534
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.