510(k) K092449 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Great Neck NY, US |
| Decision | Substantially Equivalent, Aug 30, 2010 |
| Received | Aug 10, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092449
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2026 | Mindray DS USA, Inc. BeneView Series. Operator's Manuals: T5 / T8 Open, Classified |
MHX | None listed |
| Sep 4, 2015 | Mindray DS USA, Inc. dba Mindray North America Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms)
Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological Terminated |
MHX | None listed |
| Dec 19, 2014 | Mindray DS USA, Inc. dba Mindray North America DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors .
Intended to be used for Terminated |
MHX | None listed |
| May 13, 2014 | Mindray DS USA, Inc. dba Mindray North America DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhyth Terminated |
MHX | None listed |
| Dec 11, 2012 | Mindray DS USA, Inc. d.b.a. Mindray North America DPM 6/7 Patient Monitor
Manufactured in China for :
Mindray DS USA, Inc.
800 MacArthur Blvd.
Mahwah, NJ 07430 USA.
Intended to be used for monitoring, displaying, reviewing, storing and alarming of Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.