510(k) K031849 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX
| Applicant | Datascope Corp., Mahwh NJ, US |
| Decision | Substantially Equivalent, Sep 9, 2003 |
| Received | Jun 16, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K031849
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2005 | Datascope Corp Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs. Monitor can monitor, display, trend and print a patient''s physiological parameters. The device has a 12.1 inch Terminated |
DRT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.