510(k) K102004 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
ENDEAVOUR MONITORING SYSTEM
| Applicant | Mindray DS USA, Inc., Mahwh NJ, US |
| Decision | Substantially Equivalent, Sep 10, 2010 |
| Received | Jul 15, 2010 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K102004
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 25, 2013 | Mindray DS USA, Inc. dba Mindray North America Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms)
Product Usage:
The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare p Terminated |
MHX | None listed |
| Dec 17, 2012 | Mindray DS USA, Inc. d.b.a. Mindray North America Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China
Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China
One prod Terminated |
MHX | None listed |
| Aug 28, 2012 | Mindray DS USA, Inc. d.b.a. Mindray North America V Series Patient Monitors; Mindray DS USA, Inc.
Product Usage:
The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indicati Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.