510(k) K251480
K251480 is an FDA 510(k) premarket notification submitted by Neurotronics, LLC for the device "PV01 PVDF Effort Sensor". The FDA issued a decision of Substantially Equivalent on August 29, 2025. The device falls under product code SFK (Respiratory Effort Belt For Polysomnography), a Class II device regulated under 21 CFR 882.1400. Neurotronics, LLC has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 2025
- Date Received
- May 13, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Respiratory Effort Belt For Polysomnography
- Device Class
- Class II
- Regulation Number
- 882.1400
- Review Panel
- AN
- Submission Type
To assess respiratory/breathing effort by measuring the movement of chest and abdominal walls. The belts function as accessories to sleep/polysomnography (PSG) and home sleep apnea test (HSAT) systems.