CNS-EP SYSTEM AND EP 1.0 SOFTWARE— 510(k) K860240

Name: FDA 510(k) clearance K860240
Creator: U.S. Food and Drug Administration
Published: 1986-04-17

Substantially Equivalent

Cns, Inc.

FDA 510(k) clearance K860240 for CNS-EP SYSTEM AND EP 1.0 SOFTWARE, Substantially Equivalent on 1986-04-17. Applicant: Cns, Inc.. Device class: 2.

Clearance details

Applicant: Cns, Inc.
Product code: Code GWF
Device class: Class 2
Regulation: 21 CFR 882.1870
Advisory panel: Neurology
Date received: 1986-01-23
Decision date: 1986-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWF

view all

K253301 — BraiN20® (BraiN20)2026-06-27
K252842 — SafeOp 3: Neural Informatix System2026-01-11
K243982 — Nicolet EDX2025-01-22
K243495 — Natus Ultrapro S100 (982A0594)2024-12-12
K242345 — Delphi Stimulator2024-11-05

More clearances from Cns, Inc.

view all

K955711 — BREATHE RIGHT NASAL STRIP1996-05-30
K954914 — BREATHE RIGHT NASAL STRIP1996-02-27
K953772 — BREATHE RIGHT NASAL STRIP1995-10-20
K950273 — SLEEP TEST(TM)1995-09-19
K921220 — BREATHE RIGHT1993-10-07

Adverse events under product code GWF

product code GWF

Malfunction: 2,364
Other: 4
Total: 2,368

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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