Respiratory Effort Belt For Polysomnography

SFK · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1400

Classification

FDA Product Code: SFK
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.1400
Review panel: AN
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown