Diagnostic Neurosurgical Microscope Filter

QFX · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.4950

Classification

FDA Product Code: QFX
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.4950
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A diagnostic neurosurgical microscope filter is a device intended for use during neurosurgery to visualize fluorescence and enhance visualization of tissue associated with a specific disease or condition.

Market data

Cleared 510(k) submissions: 5
Registered establishments: 7

Source

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