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Respiratory Effort Belt For Polysomnography

FDA product code SFK · 1 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.1400
Review panel
AN
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-08-29 – 2025-08-29

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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