510(k) K162234 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Truscope Ultra Patient Monitor
| Applicant | Guangdong Biolight Meditech Co., Ltd., Zhuhai,, CN |
| Decision | Substantially Equivalent, Jan 4, 2017 |
| Received | Aug 9, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162234
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.