Brain Stimulation Programming Planning Software.

QQC · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5855

Classification

FDA Product Code: QQC
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.5855
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.

Market data

Cleared 510(k) submissions: 3
Registered establishments: 3

Source

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