510(k) K170712 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Accutorr 7/VS-900 Vital Signs Monitor
| Applicant | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Aug 2, 2017 |
| Received | Mar 9, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170712
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2019 | Mindray DS USA, Inc. dba Mindray North America Rosie4 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 monitoring physiologic parameters, includin Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.