510(k) K182821 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Accutorr 7/VS-900/VS-900c Vital Signs Monitor
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Mar 27, 2019 |
| Received | Oct 4, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182821
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2019 | Mindray DS USA, Inc. dba Mindray North America Accutorr 7 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, inc Terminated |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.