NEUROSCOPE SEEG— 510(k) K861884

Name: FDA 510(k) clearance K861884
Creator: U.S. Food and Drug Administration
Published: 1986-10-14

Substantially Equivalent

Siegen Corp.

FDA 510(k) clearance K861884 for NEUROSCOPE SEEG, Substantially Equivalent on 1986-10-14. Applicant: Siegen Corp.. Device class: 2.

Clearance details

Applicant: Siegen Corp.
Product code: Code GWO
Device class: Class 2
Regulation: 21 CFR 882.5320
Advisory panel: Neurology
Date received: 1986-05-15
Decision date: 1986-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Siegen Corp.

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K871964 — SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU.1987-10-01
K862430 — SIEGEN HEADPHONES1986-09-26
K844616 — SIEGEN VISUAL STIMULATOR1985-02-14
K844646 — SIEGEN SURFACE ELECTRODES1984-12-11
K843464 — SIEGEN NEUROSCOPE1984-11-20

Adverse events under product code GWO

product code GWO

Malfunction: 583
Total: 583

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.