510(k) K993531 ยท DSI Detector And Alarm, Arrhythmia
PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
| Applicant | Datascope Corp., Paramus NJ, US |
| Decision | Substantially Equivalent, Jan 13, 2000 |
| Received | Oct 18, 1999 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K993531
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Datascope Corp Passport 2/Passport 2 LT Vital Signs Monitor. Multi-parameter patient monitoring system. Terminated |
MSX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.