SFK · Respiratory Effort Belt For Polysomnography
Neurology · 21 CFR 882.1400 · Class 2
Overview
| Product Code | SFK |
|---|---|
| Device Name | Respiratory Effort Belt For Polysomnography |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251480 | PV01 PVDF Effort Sensor | Neurotronics, LLC | Aug 29, 2025 | SESE |
Top Applicants
- Neurotronics, LLC — 1 clearance
