Data / Medical devices / Sweden / Senzime AB
Senzime AB: FDA-registered device maker in Uppsala, Sweden, 4 510(k) clearances
Senzime AB is registered with the FDA (registration 3016490024) in Uppsala, Sweden. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 22, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016490024
- Address
- Verkstadsgatan 8, Uppsala, Sweden, 75323
- Owner or operator
- Senzime AB (10062527)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- February 7, 2020
- Registered through
- 2026
- Brand names listed
- TetraGraph Neuromuscular Transmission Monitor (NMT)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Monitor, Breathing Frequency | BZQ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Spirometer, Monitoring (W/Wo Alarm) | BZK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Peripheral, Electric | KOI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 22, 2026 | K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) | KOI | Substantially Equivalent | Senzime AB | accessdata.fda.gov |
| August 17, 2022 | K220530 | Tetragraph Neuromuscular Transmission Monitor | KOI | Substantially Equivalent | Senzime AB | accessdata.fda.gov |
| December 17, 2019 | K192595 | ExSpiron 2Xi | BZK | Substantially Equivalent | Respiratory Motion | accessdata.fda.gov |
| October 18, 2019 | K190795 | Tetragraph Neuromuscular Transmission Monitor | KOI | Substantially Equivalent | Senzime AB | accessdata.fda.gov |
Compare with other makers
- All makers of Spirometer, Monitoring (W/Wo Alarm)
- All makers of Monitor, Breathing Frequency
- All makers of Stimulator, Nerve, Peripheral, Electric
Updated May 22, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.