510(k) K900385 ยท DSI Detector And Alarm, Arrhythmia
ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE
| Applicant | Parexel Intl. Corp., Cambridge MS, US |
| Decision | Substantially Equivalent, Jul 9, 1991 |
| Received | Jan 29, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900385
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.