FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)
K Number: K261098
·
Decision May 22, 2026
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
28
Applicant Total
3
Review Days
50
Basic Information
- Device Name
- TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017)
- K Number
- K261098
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.2775
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Senzime AB
- Date Received
- April 2, 2026
- Decision Date
- May 22, 2026
- Product Code
- KOI
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KOI | Stimulator, Nerve, Peripheral, Electric | FDA class 2 | Anesthesiology |
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