Product code SFK

Device name

Respiratory Effort Belt For Polysomnography

Medical specialty

Neurology

Device class

2

Regulation number

882.1400

Review panel

AN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset