510(k) K143506 ยท GXY Electrode, Cutaneous
BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES)
| Applicant | Covidien, Boulder CO, US |
| Decision | Substantially Equivalent, Apr 16, 2015 |
| Received | Dec 10, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143506
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.