THE VANGUARD SYSTEM— 510(k) K941551

Name: FDA 510(k) clearance K941551
Creator: U.S. Food and Drug Administration
Published: 1995-01-13

Substantially Equivalent

Cleveland Clinic Foundation

FDA 510(k) clearance K941551 for THE VANGUARD SYSTEM, Substantially Equivalent on 1995-01-13. Applicant: Cleveland Clinic Foundation. Device class: 2.

Clearance details

Applicant: Cleveland Clinic Foundation
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1994-03-30
Decision date: 1995-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWQ

view all

K261604 — Enobio Dx (3 models)2026-06-13
K260455 — New Wave System2026-03-13
K233403 — Flexset System2024-04-30
K231366 — Neuronaute Plus2023-11-09
K221959 — Q212023-08-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.