SFK

Respiratory Effort Belt For Polysomnography

Product code

SFK

Device name

Respiratory Effort Belt For Polysomnography

Device class

Class 2

21 CFR

21 CFR 882.1400

Medical specialty

Neurology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-08-29.

1 summaries are archived here for direct download.