PV01 PVDF Effort Sensor
FDA 510(k) clearance K251480 · decided 2025-08-29
Clearance details
- K-number
- K251480
- Device name
- PV01 PVDF Effort Sensor
- Applicant
- Neurotronics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-05-13
- Decision date
- 2025-08-29
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- SFK
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Alachua, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Neurotronics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.