510(k) K132037 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
VITAL SIGNS MONITOR
| Applicant | Mindray North America, Mahwh NJ, US |
| Decision | Substantially Equivalent, May 16, 2014 |
| Received | Jul 1, 2013 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K132037
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2019 | Mindray DS USA, Inc. dba Mindray North America Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic param Terminated |
MWI | None listed |
| Oct 1, 2019 | Mindray DS USA, Inc. dba Mindray North America Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic paramete Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.