510(k) K020550 ยท DSI Detector And Alarm, Arrhythmia
PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
| Applicant | Datascope Corp., Mahwh NJ, US |
| Decision | Substantially Equivalent, Aug 28, 2002 |
| Received | Feb 19, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020550
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2005 | Datascope Corp Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physiological monitor designed to monitor and display the following physiological parameters: ECG, Heart Rate deri Terminated |
DRT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.