510(k) K180788 ยท BZK Spirometer, Monitoring (W/Wo Alarm)
Gas Module 3
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Oct 24, 2018 |
| Received | Mar 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180788
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.