510(k) K003999 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010
| Applicant | American Telecare, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Jun 28, 2001 |
| Received | Dec 26, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003999
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.