SFK — Respiratory Effort Belt For Polysomnography Class II
FDA product code SFK covers "Respiratory Effort Belt For Polysomnography", a Class II medical device regulated under 21 CFR 882.1400. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SFK
- Device Class
- Class II
- Regulation Number
- 882.1400
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Neurology
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251480 | neurotronics | PV01 PVDF Effort Sensor | August 29, 2025 |