SFK

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Respiratory Effort Belt For Polysomnography

Device class

Class II (moderate risk)

Regulation

21 CFR 882.1400

Medical specialty

Neurology

FDA 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.

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