Active Noise Attenuation System For Infant Incubators

QWX · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5405

Classification

FDA Product Code: QWX
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 880.5405
Review panel: HO
Medical specialty: General Hospital
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A device system which captures the environmental noise and outputs noise cancelling acoustic sound waves to attenuate noise in infant incubators in the healthcare environment.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

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