510(k) K091834 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
PASSPORT V MONITOR, MODEL 0998-00-6100
| Applicant | Datascope Corp., Patient Monitoring Division, Mahwh NJ, US |
| Decision | Substantially Equivalent, Jul 15, 2009 |
| Received | Jun 22, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091834
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2015 | Mindray DS USA, Inc. dba Mindray North America Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms)
Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. Terminated |
MHX | None listed |
| Jun 10, 2010 | Mindray DS USA, Inc., dba Datascope Patient Monitoring Passport V Monitor: Mindray, North America. Mindray DS USA, Inc. Mahwah, NJ 07430.
Intended for intra hospital use under the direct supervision of a healthcare practitioner for the monitoring of var Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.