FDA product code SFK

Respiratory Effort Belt For Polysomnography

Neurology·Class 2·21 CFR 882.1400
US regulatory classifications
US Product Code (FDA)
SFK
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 882.1400
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Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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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About this record

Respiratory Effort Belt For Polysomnography is a medical device type in the Neurology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.