510(k) K132026 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21
| Applicant | Mindray DS USA, Inc., Mahwh NJ, US |
| Decision | Substantially Equivalent, Dec 20, 2013 |
| Received | Jul 1, 2013 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K132026
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2014 | Mindray DS USA, Inc. dba Mindray North America Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1
The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.