SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU.— 510(k) K871964

Name: FDA 510(k) clearance K871964
Creator: U.S. Food and Drug Administration
Published: 1987-10-01

Substantially Equivalent

Siegen Corp.

FDA 510(k) clearance K871964 for SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU., Substantially Equivalent on 1987-10-01. Applicant: Siegen Corp.. Device class: 2.

Clearance details

Applicant: Siegen Corp.
Product code: Code GWF
Device class: Class 2
Regulation: 21 CFR 882.1870
Advisory panel: Neurology
Date received: 1987-05-20
Decision date: 1987-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Siegen Corp.

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K861884 — NEUROSCOPE SEEG1986-10-14
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 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.