510(k) K261098 ยท KOI Stimulator, Nerve, Peripheral, Electric
TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)
| Applicant | Senzime AB, Uppsala, SE |
| Decision | Substantially Equivalent, May 22, 2026 |
| Received | Apr 2, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261098
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.