External Compression Device For Internal Jugular Vein Compression

QNX · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 890.3050

Classification

FDA Product Code: QNX
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 890.3050
Review panel: PM
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

External compression device for internal jugular vein compression. An external compression device for internal jugular vein compression is a non-invasive device that is intended to increase intracranial blood volume to reduce the occurrence of specific changes in the brain following head impacts sustained from the environment of use.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

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